Clinical Trials for Diarrhea

Currently registered clinical trials for Diarrhea from ClinicalTrials.gov. 19 recruiting, 50 total studies.

This content is for informational purposes only. Always consult a healthcare professional.

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

StatusRecruiting
PhasePhase 2
SponsorUniversity of Utah
Enrollment120
Study TypeINTERVENTIONAL
ConditionsMultiple 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

StatusRecruiting
PhasePhase 2
SponsorMadhusudan (Madhu) Grover, MBBS
Enrollment43
Study TypeINTERVENTIONAL
ConditionsIrritable 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

StatusRecruiting
PhasePhase 3
SponsorVedanta Biosciences, Inc.
Enrollment852
Study TypeINTERVENTIONAL
ConditionsClostridium 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

StatusRecruiting
PhaseN/A
SponsorInstitute of Gastroenterology and Hepatology, Vietnam
Enrollment60
Study TypeINTERVENTIONAL
ConditionsIrritable 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)

StatusRecruiting
PhaseN/A
SponsorJohns Hopkins Bloomberg School of Public Health
Enrollment1600
Study TypeINTERVENTIONAL
ConditionsDiarrhea 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

StatusRecruiting
PhaseN/A
SponsorRAND
Enrollment103920
Study TypeINTERVENTIONAL
ConditionsDiarrhea 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

StatusRecruiting
PhaseN/A
SponsorThe First Affiliated Hospital of Soochow University
Enrollment46
Study TypeINTERVENTIONAL
ConditionsIrritable 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

StatusRecruiting
PhaseN/A
SponsorMayo Clinic
Enrollment24
Study TypeINTERVENTIONAL
ConditionsBile 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

StatusRecruiting
PhaseN/A
SponsorUniversity Medical Center Ho Chi Minh City (UMC)
Enrollment90
Study TypeINTERVENTIONAL
ConditionsDiarrhea-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

StatusRecruiting
PhaseN/A
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment308
Study TypeINTERVENTIONAL
ConditionsHER2-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

StatusRecruiting
PhasePhase 3
SponsorCrinetics Pharmaceuticals Inc.
Enrollment141
Study TypeINTERVENTIONAL
ConditionsCarcinoid 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

StatusRecruiting
PhasePhase 2
SponsorMark Pimentel, MD
Enrollment225
Study TypeINTERVENTIONAL
ConditionsIBS (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

StatusRecruiting
PhaseN/A
SponsorShenzhen Hospital of Southern Medical University
Enrollment200
Study TypeINTERVENTIONAL
ConditionsChemotherapy-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

StatusRecruiting
PhaseN/A
SponsorNovoNatum Ltd
Enrollment140
Study TypeINTERVENTIONAL
ConditionsInfantile 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)

StatusRecruiting
PhasePhase 2
SponsorGlaxoSmithKline
Enrollment420
Study TypeINTERVENTIONAL
ConditionsIrritable 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)

StatusRecruiting
PhasePhase 2
SponsorEli Lilly and Company
Enrollment531
Study TypeINTERVENTIONAL
ConditionsIrritable 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

StatusRecruiting
PhaseN/A
SponsorUniversity Hospital of Patras
Enrollment1400
Study TypeINTERVENTIONAL
ConditionsRadial 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

StatusRecruiting
PhaseN/A
SponsorAydin Adnan Menderes University
Enrollment180
Study TypeOBSERVATIONAL
ConditionsGastroenteritis 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.

StatusRecruiting
PhasePhase 2
SponsorLeeuwenhoek Laboratories Co. Ltd.
Enrollment80
Study TypeINTERVENTIONAL
ConditionsBreast 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

StatusActive, not recruiting
PhasePhase 1
SponsorMemorial Sloan Kettering Cancer Center
Enrollment4
Study TypeINTERVENTIONAL
ConditionsFecal 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

StatusActive, not recruiting
PhaseN/A
SponsorTemple University
Enrollment908
Study TypeINTERVENTIONAL
ConditionsDiarrhea; 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)

StatusActive, not recruiting
PhaseN/A
SponsorStanford University
Enrollment800
Study TypeINTERVENTIONAL
ConditionsAscaris 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

StatusActive, not recruiting
PhaseN/A
SponsorDaniel Leung
Enrollment30
Study TypeINTERVENTIONAL
ConditionsDiarrhea 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

StatusNot yet recruiting
PhasePhase 4
SponsorMd. Aminul Islam
Enrollment76
Study TypeINTERVENTIONAL
ConditionsIBS-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

StatusNot yet recruiting
PhaseN/A
SponsorUniversity of California, Berkeley
Enrollment2655
Study TypeINTERVENTIONAL
ConditionsDiarrhea; 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)

StatusNot yet recruiting
PhasePhase 3
SponsorBeijing Hospital of Traditional Chinese Medicine
Enrollment636
Study TypeINTERVENTIONAL
ConditionsIBS, 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

StatusNot yet recruiting
PhaseN/A
SponsorSwiss Tropical & Public Health Institute
Enrollment1040
Study TypeINTERVENTIONAL
ConditionsBreastfeeding; 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

StatusNot yet recruiting
PhaseN/A
SponsorTang-Du Hospital
Enrollment60
Study TypeINTERVENTIONAL
ConditionsCritical 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

StatusNot yet recruiting
PhasePhase 3
SponsorNanjing First Hospital, Nanjing Medical University
Enrollment106
Study TypeINTERVENTIONAL
ConditionsDiarrhea-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

StatusNot yet recruiting
PhaseN/A
SponsorGazi University
Enrollment100
Study TypeOBSERVATIONAL
ConditionsMorbid 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

StatusNot yet recruiting
PhaseN/A
SponsorChildren Hospital and Institute of Child Health, Lahore
Enrollment138
Study TypeINTERVENTIONAL
ConditionsAcute 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

StatusEnrolling by invitation
PhaseN/A
SponsorIndiana University
Enrollment200
Study TypeOBSERVATIONAL
ConditionsFunctional 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

StatusEnrolling by invitation
PhaseN/A
SponsorMayo Clinic
Enrollment4001
Study TypeOBSERVATIONAL
ConditionsInflammatory 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

StatusCompleted
PhaseN/A
SponsorNantes University Hospital
Enrollment40
Study TypeOBSERVATIONAL
ConditionsDiarrhea
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

StatusCompleted
PhasePhase 1 / Phase 2
SponsorThe University of Texas Health Science Center, Houston
Enrollment123
Study TypeINTERVENTIONAL
ConditionsAutism 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

StatusCompleted
PhaseN/A
SponsorMassachusetts General Hospital
Enrollment31
Study TypeINTERVENTIONAL
ConditionsFecal 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

StatusCompleted
PhasePhase 1 / Phase 2
SponsorGlaxoSmithKline
Enrollment551
Study TypeINTERVENTIONAL
ConditionsDiarrhoea
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®

StatusCompleted
PhasePhase 2
SponsorJames Varani
Enrollment35
Study TypeINTERVENTIONAL
ConditionsUlcerative 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

StatusCompleted
PhaseN/A
SponsorUniversity of Oxford
Enrollment1183
Study TypeINTERVENTIONAL
ConditionsMalaria; 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

StatusCompleted
PhaseN/A
SponsorFundació Sant Joan de Déu
Enrollment22
Study TypeINTERVENTIONAL
ConditionsPediatric 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

StatusCompleted
PhasePhase 3
SponsorFerring Pharmaceuticals
Enrollment41
Study TypeINTERVENTIONAL
ConditionsClostridium 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.

StatusCompleted
PhasePhase 2
SponsorImmuron Ltd.
Enrollment63
Study TypeINTERVENTIONAL
ConditionsDiarrhea; 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

StatusCompleted
PhaseN/A
SponsorUniversity of North Carolina, Chapel Hill
Enrollment30
Study TypeINTERVENTIONAL
ConditionsAlpha-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

StatusCompleted
PhasePhase 2
SponsorHunazine Biotech S.L.
Enrollment150
Study TypeINTERVENTIONAL
ConditionsCholera
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

StatusCompleted
PhaseN/A
SponsorBoehringer Ingelheim
Enrollment18
Study TypeOBSERVATIONAL
ConditionsIdiopathic 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

StatusCompleted
PhasePhase 2
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Enrollment72
Study TypeINTERVENTIONAL
ConditionsEscherichia 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

StatusCompleted
PhaseN/A
SponsorJimma University
Enrollment835
Study TypeINTERVENTIONAL
ConditionsDiarrheal 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

StatusCompleted
PhaseN/A
SponsorLiaquat University of Medical & Health Sciences
Enrollment1100
Study TypeINTERVENTIONAL
ConditionsAntibiotic-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…

StatusCompleted
PhaseN/A
SponsorRadicle Science
Enrollment500
Study TypeINTERVENTIONAL
ConditionsGas 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

StatusTerminated
PhasePhase 3
SponsorCenters for Disease Control and Prevention
Enrollment482
Study TypeINTERVENTIONAL
ConditionsDiarrhea 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…