Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Diarrhea from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 50
- Recruiting: 19
- Active, not recruiting: 4
- Completed: 16
- Other: 11
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT05405387 — Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Enrollment | 120 |
| Study Type | INTERVENTIONAL |
| Conditions | Multiple Myeloma; Plasma Cell Leukemia |
| Interventions | ; |
A randomized placebo controlled, phase 2 study of budesonide in subjects with multiple myeloma undergoing autologous stem cell transplant (ACST). The study includes a run-in period with 20 patients.
NCT05776914 — Fecal Microbiota Transplantation for IBS
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Madhusudan (Madhu) Grover, MBBS |
| Enrollment | 43 |
| Study Type | INTERVENTIONAL |
| Conditions | Irritable Bowel Syndrome; Diarrhea |
| Interventions | ; |
The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.
NCT06237452 — VE303 for Prevention of Recurrent Clostridioides Difficile Infection
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vedanta Biosciences, Inc. |
| Enrollment | 852 |
| Study Type | INTERVENTIONAL |
| Conditions | Clostridium Difficile; Clostridium Difficile Infections; Clostridium Difficile Infection Recurrence; Clostridioides Difficile Infection; Clostridioides Difficile Infection Recurrence |
| Interventions | ; |
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
NCT07656623 — Effects of the Multispecies Probiotic Ecologic Barrier in IBS Patients With Upper GI Symptoms and Anxiety, Depression, or Stress
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Institute of Gastroenterology and Hepatology, Vietnam |
| Enrollment | 60 |
| Study Type | INTERVENTIONAL |
| Conditions | Irritable Bowel Syndrome With Diarrhea |
| Interventions | ; |
The aim of this clinical trial is to find out whether Ecologic Barrier is effective in supporting the treatment of irritable bowel syndrome (IBS) in adults. The main questions that this trial aims to answer are:
- Does Ecologic Barrier help improve IBS severity when added to standard IBS treatment?
- Does Ecologic Barrier help improve symptoms of anxiety, depression, and stress in patients wit…
NCT06498817 — Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Johns Hopkins Bloomberg School of Public Health |
| Enrollment | 1600 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea Infectious; Cholera |
| Interventions | ; |
The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections, diarrheal disease, and stunting among young children in intervention households, and had significant sustained impacts on handwashing with soap behaviors and impro…
NCT06444633 — The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea
| Status | Recruiting |
| Phase | N/A |
| Sponsor | RAND |
| Enrollment | 103920 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea Toddler |
| Interventions |
The aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:
- RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupl…
NCT07581756 — Repeated Transcranial Magnetic Stimulation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
| Status | Recruiting |
| Phase | N/A |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Enrollment | 46 |
| Study Type | INTERVENTIONAL |
| Conditions | Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea (IBS-D); Repetitive Transcranial Magnetic Stimulation (rTMS); Chronic Diarrhea; Intestinal Flora |
| Interventions | ; |
Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients.
Design: This is a clinical trial that uses clinical symptom scales to assess the th…
NCT06609148 — Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Mayo Clinic |
| Enrollment | 24 |
| Study Type | INTERVENTIONAL |
| Conditions | Bile Acid Malabsorption; Bile Acid Diarrhea |
| Interventions | ; |
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
NCT07000383 — Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) |
| Enrollment | 90 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea-predominant Irritable Bowel Syndrome; Irritable Bowel Syndrome of Diarrhea Type (IBS-D) |
| Interventions | ; |
This clinical study aims to investigate the effectiveness and safety of Gelsectan, a treatment containing xyloglucan, in adults diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) in Vietnam. IBS-D is a common digestive disorder that causes frequent diarrhea along with abdominal pain and bloating, significantly affecting patients’ daily life and wellbeing.
The main goal of the…
NCT06892093 — Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Enrollment | 308 |
| Study Type | INTERVENTIONAL |
| Conditions | HER2-positive Breast Cancer; Diarrhea Caused by Drug; Neratinib |
| Interventions | ; ; |
This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.
Study Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive…
NCT07087054 — Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Crinetics Pharmaceuticals Inc. |
| Enrollment | 141 |
| Study Type | INTERVENTIONAL |
| Conditions | Carcinoid Syndrome; Carcinoid; Carcinoid Tumor; Carcinoid Tumor of Ileum; Carcinoid Tumor of Cecum |
| Interventions | ; |
A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in parti…
NCT06727422 — Efficacy of Rifaximin With NAC in IBS-D
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mark Pimentel, MD |
| Enrollment | 225 |
| Study Type | INTERVENTIONAL |
| Conditions | IBS (Irritable Bowel Syndrome); IBS-D (Diarrhea-predominant) |
| Interventions | ; ; |
The purpose of this study is to examine the effectiveness of using a combination of a drug, rifaximin and a dietary supplement, N-acetyl-L-cysteine (NAC), to treat patients with irritable bowel syndrome with diarrhea (IBS-D). Rifaximin is one of the standard treatments for IBS-D and is FDA approved. While rifaximin is safe and effective for treating symptoms in patients with IBS-D, many patient…
NCT07309315 — Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Shenzhen Hospital of Southern Medical University |
| Enrollment | 200 |
| Study Type | INTERVENTIONAL |
| Conditions | Chemotherapy-induced Diarrhea |
| Interventions | ; |
The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the…
NCT07444008 — Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
| Status | Recruiting |
| Phase | N/A |
| Sponsor | NovoNatum Ltd |
| Enrollment | 140 |
| Study Type | INTERVENTIONAL |
| Conditions | Infantile Colics; Constipation; Infantile Diarrhea; Atopic Dermatitis |
| Interventions | ; |
This is a randomized, single-blind, placebo-controlled study to evaluate the efficacy of the dietary supplement BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) in managing functional gastrointestinal disorders and cutaneous symptoms of food allergy in infants during the first months of life.
The aim of the study is to assess clinical effects of BioAmicus C…
NCT07519395 — A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | GlaxoSmithKline |
| Enrollment | 420 |
| Study Type | INTERVENTIONAL |
| Conditions | Irritable Bowel Syndrome |
| Interventions | ; |
This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.
NCT07545759 — A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eli Lilly and Company |
| Enrollment | 531 |
| Study Type | INTERVENTIONAL |
| Conditions | Irritable Bowel Syndrome; Diarrhea |
| Interventions | ; |
The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.
The study will last approximately 35 weeks.
NCT07617259 — UltraSound Guided Distal Radial Artery vS Conventional Transradial Access for Interventional Coronary Angiography
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University Hospital of Patras |
| Enrollment | 1400 |
| Study Type | INTERVENTIONAL |
| Conditions | Radial Artery Access; Distal Radial Artery Access (dTRA) |
| Interventions |
Comparative study of ultrasound-guided distal radial access versus conventional radial access regarding the incidence of vascular access crossover.
NCT07610382 — Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Aydin Adnan Menderes University |
| Enrollment | 180 |
| Study Type | OBSERVATIONAL |
| Conditions | Gastroenteritis Acute; Dehydration; Acidosis, Metabolic; Diarrhea; Vomiting |
Acute gastroenteritis (AGE) is among the most common reasons for paediatric emergency visits. Children with significant dehydration often require intravenous (IV) fluid therapy. Two main types of IV crystalloid solutions are currently used in clinical practice: 0.9% sodium chloride (normal saline, NS) and balanced crystalloids such as Isolyte-S, which contain acetate and gluconate as bicarbonat…
NCT07605728 — Probiotics for Abemaciclib-Induced Abdominal Discomfort.
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Leeuwenhoek Laboratories Co. Ltd. |
| Enrollment | 80 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer; Chemotherapy-induced Diarrhea |
| Interventions | ; |
This study aims to evaluate whether the addition of probiotics can help reduce abdominal discomfort (such as diarrhea) in breast cancer patients receiving Abemaciclib treatment. Abemaciclib is an effective targeted therapy but often causes gastrointestinal side effects. While Loperamide is the standard treatment for diarrhea, this study explores if probiotics can provide additional relief and i…
Active, Not Recruiting
NCT04883762 — Stool Transplant to Control Treatment-related Diarrhea
| Status | Active, not recruiting |
| Phase | Phase 1 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Enrollment | 4 |
| Study Type | INTERVENTIONAL |
| Conditions | Fecal Microbiota Transplantation (FMT) |
| Interventions |
This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea.
FMT uses a liquid preparation of stool collected from a healthy donor with normal (healthy) bacteria; this liquid is infused into the small or large intestine of a recipient during a colonoscopy procedure. The study researc…
NCT04826991 — Wells and Enteric Disease Transmission
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Temple University |
| Enrollment | 908 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea; Gastrointestinal Infection; Respiratory Viral Infection; Waterborne Diseases |
| Interventions | ; |
Approximately 40 million people in the US are served by private, and frequently untreated, wells. Our best estimate is that 1.3 million cases of gastrointestinal illnesses (GI) per year are attributed to consuming water from untreated private wells in the US, but in reality, there are no robust epidemiological data that can be used to estimate cases of GI attributable to these sources. We propo…
NCT05372068 — Cement flooRs AnD chiLd hEalth (CRADLE)
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Stanford University |
| Enrollment | 800 |
| Study Type | INTERVENTIONAL |
| Conditions | Ascaris Lumbricoides Infection; Necator Americanus Infection; Trichuris Trichiura; Infection; Diarrhea |
| Interventions |
This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudin…
NCT07538531 — The Utility and Feasibility of Accessible Diarrhea Etiology Prediction Tool (ADEPT) in an Informal Healthcare Setting
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Daniel Leung |
| Enrollment | 30 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea Infectious; Algorithms; Decision Support Systems, Clinical; Clinical Decision-making |
| Interventions |
Diarrheal disease remains a leading cause of morbidity and mortality for children under 5 globally. Accepted best practice for managing diarrhea in the absence of blood or suspicion of cholera is rehydration, however in resource poor areas antibiotics are still prescribed at high rates due to pressures such as financial incentives, caregiver expectations, and diagnostic uncertainty. Informal he…
Not Yet Recruiting
NCT07574320 — Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Sponsor | Md. Aminul Islam |
| Enrollment | 76 |
| Study Type | INTERVENTIONAL |
| Conditions | IBS-D (Diarrhea-predominant) |
| Interventions | ; |
Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D.
Patients of both sex of age group 18-65 years attending gastroenterology outpatient department Dhaka Medical College Hospi…
NCT07601503 — Evaluating In-line Chlorination in Nigeria
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | University of California, Berkeley |
| Enrollment | 2655 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea; Water Quality; Adoption |
| Interventions |
This study evaluates the implementation and effectiveness of in-line chlorination (ILC) for improving drinking water quality in rural Nigeria. Unsafe drinking water remains a major contributor to diarrheal disease, particularly among children under five. Inline chlorination is a passive water treatment approach that automatically doses chlorine at community water systems without requiring elect…
NCT07610434 — Phase III Clinical Trial of Changji’an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Hospital of Traditional Chinese Medicine |
| Enrollment | 636 |
| Study Type | INTERVENTIONAL |
| Conditions | IBS, Diarrhea Predominant |
| Interventions | ; |
This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trial. Its purpose is to evaluate the efficacy and safety of Changji’an Capsules in subjects with diarrhea-predominant irritable bowel syndrome (liver-qi invading spleen syndrome) after 8 weeks of treatment.
NCT07569172 — Improved Child Nutrition and Development Through Social Transfers
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Swiss Tropical & Public Health Institute |
| Enrollment | 1040 |
| Study Type | INTERVENTIONAL |
| Conditions | Breastfeeding; Breastfeeding Education; Breastfeeding Duration; Breastfeeding Continuation; Child Growth |
| Interventions |
The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are:
- Does the social transfer increase complementary breastfeeding rates at 24-months postpartum?
- Does the social transf…
NCT07683364 — Bristol Stool Scale-Based Care Pathway for Enteral Nutrition-Associated Diarrhea in Critically Ill Patients
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Tang-Du Hospital |
| Enrollment | 60 |
| Study Type | INTERVENTIONAL |
| Conditions | Critical Illness; Diarrhea |
| Interventions | ; |
Enteral nutrition-associated diarrhea (ENAD) is one of the most common gastrointestinal complications in critically ill patients receiving enteral nutrition, with a reported incidence of 22.3%-63.1%. Current management lacks a standardized nursing process and relies on individual nurse experience. This study constructs a standardized nursing care pathway driven by the Bristol Stool Form Scale (…
NCT07688161 — Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Enrollment | 106 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea-predominant Irritable Bowel Syndrome |
| Interventions | ; |
This prospective, open-label, randomized controlled clinical trial aims to evaluate the clinical efficacy and safety of Jingfang Granules in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) with cold-dampness encumbering the spleen syndrome, and to explore its potential mechanisms of action. A total of 106 patients with IBS-D of cold-dampness encumbering the spleen syndrom…
NCT07668765 — GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Gazi University |
| Enrollment | 100 |
| Study Type | OBSERVATIONAL |
| Conditions | Morbid Obesity; Anorectal Diseases; Drug-Related Side Effects and Adverse Reactions; Constipation; Diarrhea |
| Interventions |
Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.
NCT07660367 — Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Children Hospital and Institute of Child Health, Lahore |
| Enrollment | 138 |
| Study Type | INTERVENTIONAL |
| Conditions | Acute Watery Diarrhea |
| Interventions | ; |
This randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Participants will receive one of the probiotic treatments along with standard therapy including oral rehydration solution and zinc supplementation. The study will evaluate the duration of diarrhea, stool frequency,…
Enrolling by Invitation
NCT01822470 — Small Intestinal Bacterial Overgrowth: A Prospective Registry
| Status | Enrolling by invitation |
| Phase | N/A |
| Sponsor | Indiana University |
| Enrollment | 200 |
| Study Type | OBSERVATIONAL |
| Conditions | Functional Dyspepsia; Small Intestinal Bacterial Overgrowth |
The purpose of this study is to investigate the prevalence of small intestinal bacterial overgrowth (SIBO) in patients who will be undergoing an enteroscopy as an outpatient procedure with symptoms of functional dyspepsia. In addition, the investigators would like to identify the types of bacteria that are present in the small intestines in patients with SIBO and compare two different diagnosti…
NCT06657001 — Enabling Microbiomics- Driven Personalized Nutrition
| Status | Enrolling by invitation |
| Phase | N/A |
| Sponsor | Mayo Clinic |
| Enrollment | 4001 |
| Study Type | OBSERVATIONAL |
| Conditions | Inflammatory Bowel Disease (IBD); Irritable Bowel Syndrome (IBS); Celiac Disease; Diarrhea; Constipation |
The goal of this observational research study is to determine how diet contributes to various gastrointestinal related conditions.
The main question investigators aim to answer is:
Are host genetics, diet, and microbiome all important determinants of GI disorders, and how their relative contribution varies among individuals and populations.
Completed Trials
NCT02875249 — Intestinal Microbiome and Chemotherapy
| Status | Completed |
| Phase | N/A |
| Sponsor | Nantes University Hospital |
| Enrollment | 40 |
| Study Type | OBSERVATIONAL |
| Conditions | Diarrhea |
| Interventions |
Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects, with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI mucositis pathophysiology are generally silent on the role of the intestinal microbiome.
The aim of the study is to ide…
NCT03514784 — Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Enrollment | 123 |
| Study Type | INTERVENTIONAL |
| Conditions | Autism Spectrum Disorder; Gastrointestinal Symptoms |
| Interventions | ; ; |
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identify…
NCT04806386 — The Role of Fiber in the Prevention and Treatment of Fecal Incontinence
| Status | Completed |
| Phase | N/A |
| Sponsor | Massachusetts General Hospital |
| Enrollment | 31 |
| Study Type | INTERVENTIONAL |
| Conditions | Fecal Incontinence; Irritable Bowel Syndrome With Diarrhea |
| Interventions |
The purpose of this study is to determine the effect of fiber supplementation on the fecal metagenome and metabolome in relation to symptoms and anorectal physiology in post-menopausal women with irritable bowel syndrome with diarrhea suffering from liquid stool fecal incontinence (FI.)
NCT05073003 — A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Sponsor | GlaxoSmithKline |
| Enrollment | 551 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhoea |
| Interventions | ; ; |
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine was first administered to adults 18 to 50 years of age in Europe. Subsequently, the vaccine was administered to a shigellosis-endemic population in Africa, first …
NCT04855799 — GI Permeability Change in Response to Aquamin®
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | James Varani |
| Enrollment | 35 |
| Study Type | INTERVENTIONAL |
| Conditions | Ulcerative Colitis; Healthy; Irritable Bowel Syndrome With Diarrhea |
| Interventions |
This trial is being completed to learn about how Aquamin® affects gastrointestinal permeability, or the control of material passing from inside the gastrointestinal tract through the gut wall into the rest of the body, in people with ulcerative colitis (UC), Irritable Bowel Syndrome with diarrhea (IBS-D), and in healthy individuals.
NCT04529434 — Star Homes Project 2
| Status | Completed |
| Phase | N/A |
| Sponsor | University of Oxford |
| Enrollment | 1183 |
| Study Type | INTERVENTIONAL |
| Conditions | Malaria; Respiratory Tract Infection Acute; Diarrhoea;Acute |
| Interventions | ; |
Malaria, pneumonia and diarrhoea causes a lot of illness in children in Tanzania and the study want to find better ways of protecting people against these diseases and want to find out if the type of house design can affect the general health of children living in the house.
NCT05507736 — Feasibility and Safety of Acupuncture With Semi-Permanent Needles for the Prevention of Irinotecan-Associated Diarrhea in Pediatric Solid Tumors: A Prospective Pilot Study
| Status | Completed |
| Phase | N/A |
| Sponsor | Fundació Sant Joan de Déu |
| Enrollment | 22 |
| Study Type | INTERVENTIONAL |
| Conditions | Pediatric Cancer; Solid Tumor |
| Interventions |
To evaluate the feasibility of an acupuncture protocol in the prevention of late diarrhea due to irinotecan in pediatric patients with solid tumors, a pre-post pilot study will be conducted.
Pre-post pilot study non-randomized, open label, single arm study. There will be a single study group that will be used at the same time as your own control. The intervention will take place for approximat…
NCT05831189 — A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection
| Status | Completed |
| Phase | Phase 3 |
| Sponsor | Ferring Pharmaceuticals |
| Enrollment | 41 |
| Study Type | INTERVENTIONAL |
| Conditions | Clostridium Difficile Infection Recurrence |
| Interventions |
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explor…
NCT05933525 — Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model.
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Immuron Ltd. |
| Enrollment | 63 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea; Travelers Diarrhea; Infectious Diarrhea |
| Interventions | ; |
This is a randomized, double-blind, placebo-controlled study to investigate a single daily dose of Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.
NCT06268717 — GI Alpha-Gal Study
| Status | Completed |
| Phase | N/A |
| Sponsor | University of North Carolina, Chapel Hill |
| Enrollment | 30 |
| Study Type | INTERVENTIONAL |
| Conditions | Alpha-Gal Syndrome; Irritable Bowel Syndrome; Diarrhea; Abdominal Pain; Vomiting |
| Interventions | ; |
This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms.
NCT06193408 — Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Hunazine Biotech S.L. |
| Enrollment | 150 |
| Study Type | INTERVENTIONAL |
| Conditions | Cholera |
| Interventions | ; |
Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence…
NCT06200714 — A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
| Status | Completed |
| Phase | N/A |
| Sponsor | Boehringer Ingelheim |
| Enrollment | 18 |
| Study Type | OBSERVATIONAL |
| Conditions | Idiopathic Pulmonary Fibrosis; Diarrhoea |
| Interventions |
This is an observational, non-interventional, and prospective post authorization safety study (PASS) that will describe the real-world proportion of patients that achieve nintedanib-associated diarrhoea control after 12 weeks of follow-up, in hospital settings in Spain. It will include outpatients (i.e., those attending ambulatory visits) with interstitial lung diseases (IPF) and other progress…
NCT06692907 — Efficacy Study of IM Administered CssBA+dmLT Against Moderate-severe Diarrhea in Human Infection Model With ETEC Strain B7A in Healthy Adults
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 72 |
| Study Type | INTERVENTIONAL |
| Conditions | Escherichia Infection |
| Interventions | ; ; |
The study is designed to evaluate the safety, immunogenicity, and efficacy of the intramuscular administration of a CS6 based vaccine (CssBA) against ETEC co-administered with double mutant labile toxin (dmLT) in preventing moderate-severe diarrhea (MSD) following challenge with ETEC strain B7A in healthy adults. Approximately 72 adult participants, divided into 4 cohorts of 18, will be randomi…
NCT07158632 — Effects of Multiple Interventions on Under-Five Diarrhea
| Status | Completed |
| Phase | N/A |
| Sponsor | Jimma University |
| Enrollment | 835 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrheal Diseases |
| Interventions | ; ; |
Diarrhea is the leading cause of death, especially in developed nations. Though there are effective interventions, diarrhea remains the leading cause of death among children in Ethiopia
NCT07234448 — Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use
| Status | Completed |
| Phase | N/A |
| Sponsor | Liaquat University of Medical & Health Sciences |
| Enrollment | 1100 |
| Study Type | INTERVENTIONAL |
| Conditions | Antibiotic-associated Diarrhea |
| Interventions | ; |
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 (Brevicillin® gocce) in preventing gastrointestinal side effects associated with antibiotic therapy using amoxicillin or amoxicillin/clavulanic acid in pediatric patients aged 0-12 years. Participants will be randomized 1:1 to receive…
NCT07230821 — Radicle GI Health RDH™: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes
| Status | Completed |
| Phase | N/A |
| Sponsor | Radicle Science |
| Enrollment | 500 |
| Study Type | INTERVENTIONAL |
| Conditions | Gas and Bloating; Diarrhea; Constipation |
| Interventions | ; |
A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes
Other (Terminated)
NCT03535272 — Bismuth Subsalicylate’s Role in the Prevention of Travelers’ Diarrhea
| Status | Terminated |
| Phase | Phase 3 |
| Sponsor | Centers for Disease Control and Prevention |
| Enrollment | 482 |
| Study Type | INTERVENTIONAL |
| Conditions | Diarrhea Travelers; Antibiotic Resistant Infection |
| Interventions | ; |
The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate (BSS) has an effect on the acquisition of travelers’ diarrhea (TD) or antimicrobial resistance (AMR) genes in fecal samples among international travelers who departed from the United States to South East Asia, South Central Asia, or Africa. Our hypotheses will be tested using a double-blinded, placebo con…