Clinical Trials for C. diff Infections

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 C. diff Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 20
• Active, not recruiting: 3
• Completed: 15
• Other: 12

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT03562741 — Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure…

NCT03325855 — Fecal Microbiota Transplant National Registry

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

NCT05739825 — Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea, and the most common health care-associated infectious disease in the United States, accounting for 15% of overall infections, nearly 30.000 deaths per year an estimated economic expense of $5 billion/year.

In the last decade, most of the burden related to CDI depends on recurrence CDI (rCDI) (3). rCDI is kn…

NCT05266807 — Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence

The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI).

Experimental arm: antibiotic treatment (vancom…

NCT06030245 — Clostridioides Difficile Infection: Analyzing CLInic Evolution and Bacterial Clearance

Clostridioides difficile (formerly Clostridium) is a bacterium found in the form of spores (resistance form) in the environment to which patients may be exposed. This bacterium used to belong to the Clostridium genus, but analysis of its 16S ribosomal RNA in 2016 led to its being distinguished from it. Once the spore has been ingested, it can germinate in vegetative form (the active form of the…

NCT06370884 — Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection

This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the su…

NCT06306014 — Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients

Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.

Currently, first-line treatment of CDI is based o…

NCT06237452 — VE303 for Prevention of Recurrent Clostridioides Difficile Infection

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).

NCT05330182 — LMN-201 for Prevention of C. Difficile Infection Recurrence

This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.

NCT06692179 — An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of A Suspension of Freeze-dried Microbiota In Patients Undergoing Colon Resection

This Phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of orally administered preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. We plan to enroll male and female patients, ages 18-75, diagnosed with colon polyps or early (stage I or II) colorectal cancer or medically refractory diverticulitis. We will recruit 40 patients total to…

NCT07261826 — Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics

This is a large-scale observational study aiming to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to restore a balanced gut microbiome.

The study will follow approximately 4,000 patients who have received or will receive FMT for conditions like recurrent C. difficile infe…

NCT06979609 — Secondary Prevention of Clostridioides Difficile Using Vancomycin

Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited. The aim of this trial is:

1) Does oral vancomycin …

NCT07285213 — Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody

The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.

NCT07374094 — Clostridioides Difficile: Understanding Responses and Treatment Effects

The goal of this observational study is to learn how different treatments for Clostridioides difficile infection (CDI) work, and which biological mechanisms are involved in recovery. The study will compare standard antibiotic treatment and fecal microbiota transplantation (FMT).

The main questions it aims to answer are:

• How do antibiotic treatment and FMT affect treatment outcome in CDI?
• …

NCT07250724 — C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.

Hospitals and clinics interested in participating in this multi-site study, please contact the people mentioned under “Contacts and Locations”.

The goal of this study is to map the risk of having a C. Difficile infection recurrence (rCDI) after being treated with standard-of-care antibiotics for a C. Difficile infection.

The main questions it aims to answer are:

• What is the recurrence rate…

NCT07401680 — Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population

This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.

NCT07328971 — Vancomycin Taper to Prevent Recurrent Clostridioides Difficile

Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides difficile infections (rCDI). The aim of this trial is:

1) For first episodes and first recurrences of CDI, to test whether a vancomycin P-T is non-inferior to 10-days …

NCT07458984 — FMT Capsules for rCDI

Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.

NCT07613645 — Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)

This study aims to evaluate the impact of diet on the gut microbiome in adults with Clostridioides difficile infection (CDI). Eligible participants will be randomized and receive meals plus different types of health counseling. Counseling visits will be by phone or online videoconference (e.g. Zoom). Meals will be provided for two weeks and then participants will be asked to continue similar me…

NCT06228352 — Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis

Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis).

Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not ful…

Active, Not Recruiting

NCT02269150 — Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.

NCT05622721 — REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs

Antimicrobial therapy can lead to disruption of the gut microbiome and infection with Clostridioides difficile, a disease associated with high morbidity and mortality, particularly among the elderly. Drawing on observations that pet ownership and close contact with pets are protective against colonization with C. difficile and recurrence of C. difficile infection, the proposed study will test t…

NCT05612672 — Evaluation of GeoHAI Implementation

Geographic Information Systems (GIS) and spatial analysis have become important tools in public health informatics but have rarely been applied to the hospital setting. In this study we apply these tools to address the challenge of Hospital Acquired Infections (HAIs) by building, implementing, and evaluating a new computer application which incorporates mapping and geographic data to assist hos…

Not Yet Recruiting

NCT07221708 — Primary Prophylaxis of Clostridioides Difficile Infection With Oral Vancomycin

The purpose of this study is to evaluate the ability of oral vancomycin in preventing Clostridioides difficile infection (CDI) in patients that are simultaneously receiving antibiotics.

Participants in this study will be placed randomly into two groups. The oral vancomycin treatment group will receive oral vancomycin two times per day simultaneously with an antibiotic plus two additional days….

NCT07569380 — Long-Term Outcomes After CDI: FMT Versus Antibiotic-Only Treatment

The goal of this observational study is to learn about the long-term effects of fecal microbiota transplantation (FMT) compared with antibiotic-only treatment in adults who were treated for Clostridioides difficile infection (CDI) at Umeå University Hospital between 2016 and 2024. The main questions it aims to answer are:

• Do patients treated with FMT maintain higher gut bacterial diversity u…

NCT06884748 — Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy

The goal of this clinical trial is to determine whether Ursodeoxycholic Acid (UDCA) can help prevent recurrence of Clostridioides difficile (C. diff) colitis when used along with standard antibiotic treatment. C. diff colitis is a serious infection that can return after treatment, and researchers want to see if UDCA can reduce this risk.

This study aims to answer three main questions. First, c…

NCT07649096 — A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile

This is a Phase 1, first-in-human, double-blind, placebo-controlled, adaptive-design, single-site study, involving dose exploration cohorts.

During Part A, up to 4 cohorts, each consisting of approximately 14 healthy adult study participants, will be randomly allocated to receive either FZ002 or placebo. Part A is designed to begin with Cohort 1 evaluating the highest proposed dose of study pr…

NCT05852587 — Xylitol Use for Decolonization of C. Difficile in Patients With IBD

This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C….

NCT07513285 — ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection

Single-arm trial to evaluate the safety and efficacy of ACX-362E [ibezapolstat] in patients with recurrent C. difficile infection (CDI).

NCT06799039 — Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease

This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.

Completed Trials

NCT02440438 — Host Immune Response to Clostridium Difficile Infection (ICD)

Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past…

NCT02467621 — Stress Ulcer Prophylaxis in the Intensive Care Unit

Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.

NCT03030248 — Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients

This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm).

Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be…

NCT04090346 — Fecal Microbiota Transplant

The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection.

Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, m…

NCT03829475 — ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI

This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Pa…

NCT04138706 — Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection

The first line therapy for an initial episode of CDI (Clostridium difficile infection) is 10-14 days of oral vancomycin which is now recommended over metronidazole in the 2018 guidelines from the Association of Medical Microbiologists and Infectious Diseases of Canada (AMMI). Although response rates for the treatment of a first episode of CDI now approach 90%, approximately 25% of patients who …

NCT04781387 — Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection

The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentr…

NCT07496502 — Effect of Oral Microbiota on MDRO Decolonization

Randomized, placebo-controlled trial to evaluate the safety and efficacy of oral intestinal microbiota capsules for decolonizing multidrug-resistant organisms (MDROs) and Clostridioides difficile in patients requiring prolonged antibiotic therapy. The primary outcome was clearance of pre-existing MDROs or C. difficile from stool 14 days post-intervention. Secondary outcomes included adverse eve…

NCT05304715 — Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection

Previous data have shown that integrated information from single nucleotide polymorphisms (SNPs) of the host DNA, interleukin 8 (IL-8) and the enrichment of the stool microbiome can indicate the patients with infection by Clostridioides difficile (CDI) who are at risk for unfavorable outcome. This integrated information is forming the BEYOND score. The aim of the BEYOND randomized clinical tria…

NCT04940468 — High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology

The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.

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

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…

NCT05835219 — REBYOTA™ Prospective Registry

This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician’s discretion and independent from the decision to enroll the patient in the study. Data will be collected from pa…

NCT06277999 — C.Difficile Observational Study

D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age with an active CDI. Participants will also be monitored for recurring episodes of diarrhea and will need to complete validated PROs and study evaluation questionnaires

NCT06639997 — Safety and Tolerability of AZD5148 in Japanese Participants

The purpose of this study is to measure safety, tolerability and PK of a single dose of AZD5148 administered via IV bolus or IM injection in healthy Japanese participants.

NCT07251127 — Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics

Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer chemotherapy drugs, which unbalance the ecosystem of the colon causing Clostridium difficile to become the predominant part of the microbiota. C. difficile is a Gram-positive a…

Available Studies

NCT03786900 — Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor.

Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor’s requirements. A basic fee will be requested to recover the cost of making th…

Other (Terminated)

NCT02667418 — Optimal Treatment for Recurrent Clostridium Difficile

The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.

Other (Suspended)

NCT03350711 — A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program

The goal of this study is to rapidly identify subjects who are eligible for the Microbiota Enrichment Program (MEP) at Emory in Atlanta, Georgia. This general screening protocol will be used to screen potential subjects for the Emory MEP and will be conducted at the Emory Clinic, the Hope Clinic of the Emory Vaccine Center and/or Emory affiliated hospitals. An electronic database will be create…

NCT03756454 — Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.

A new medication, Bezlotoxumab, has been approved for treatment of recurrent Clostridium difficile diarrhea by the U.S. Food and Drug Administration. The way this new medication works, is by binding the toxin produced by C. difficile bacteria and preventing damage to the large bowel. The toxin, and not the bacteria, is responsible for the damage, resulting in the clinical symptoms seen in patie…

NCT06536465 — The Clostridioides Difficile Trial of REC-3964

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides difficile infection (CDI).