Clostridium Difficile Infection: Clinical Trials

77 completed, 19 unknown, 18 terminated, 9 recruiting. 33 Phase 2, 23 Not applicable, 23 Phase 3, 18 Phase 1, 14 Phase 4.

By phase and status

Phase	Trials	Status
Phase 2	33	Completed 19, Terminated 8, Recruiting 2, Unknown 2, Withdrawn 2
Not applicable	23	Completed 10, Unknown 7, Recruiting 3, Terminated 2, Withdrawn 1
Phase 3	23	Completed 13, Terminated 6, Unknown 3, Recruiting 1
Phase 1	18	Completed 12, Terminated 4, Not yet recruiting 1, Unknown 1
Phase 4	14	Completed 7, Terminated 3, Withdrawn 3, Unknown 1
Early Phase 1	1	Completed 1

Follow Clostridium Difficile Infection: new trials by email Literature Review of Clostridium Difficile Infection trials Research Report on Clostridium Difficile Infection

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile FZ002, Placebo for FZ002 - Clostridium Difficile Infection	Phase 1	Not yet recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	56	2026-10-29	2026-10-30
Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients Vancomycin 125mg, Placebo - Clostridium Difficile Infection, Vancomycin Resistant Enterococci Infection	Phase 2 / Phase 3	Recruiting	Riverside University Health System Medical Center	176	2024-10-21	2025-11-10
A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection DBMF, Placebo - Clostridium Difficile Infection	Not applicable	Unknown	Vedic Lifesciences Pvt. Ltd.	20	2024-07-15	2024-06-17
Study on Clostridium Difficile Infection in Infants Clostridium Difficile Infection		Recruiting	First People's Hospital of Hangzhou	150	2024-07-01	2024-11-25
Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection Fecal filtrate transplantation, Conventional fecal microbiota transplantation - Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection	Phase 3	Unknown	University of Pecs	238	2023-11-01	2023-05-19
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology Diet Intervention - Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute	Not applicable	Completed	University of Colorado, Denver	8	2022-10-21	2026-09-10
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients FMT Capsule DE, Placebo oral capsule - Clostridium Difficile Infection	Phase 2	Withdrawn	University of Wisconsin, Madison		2022-09-01	2021-02-23
Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile Patients - Clostridium Difficile Infection	Not applicable	Unknown	Fondation Hôpital Saint-Joseph	840	2021-11-30	2023-04-07
Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection Fecal microbiota transplantion (FMT), Placebo - Clostridium Difficile Infection, Clostridioides Difficile Infection	Not applicable	Completed	Christian Lodberg Hvas	42	2021-06-02	2026-10-16
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Alanyl-glutamine - Clostridioides Difficile Infection, Clostridium Difficile Infection	Phase 2	Recruiting	University of Virginia	260	2021-06-01	2024-10-26
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gastrointestinal Diseases Biological sample collection, Questionnaire, Medical examination - Clostridium Difficile Infection, Multi Drug Resistant Organisms		Completed	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	225	2021-02-08	2022-08-04
Natural History of Clostridioides Difficile Infection Clostridium Difficile Infection, Health Care Associated Infection		Recruiting	Hospital Universitario de Valme	750	2021-01-01	2026-09-17
Initial Vancomycin Taper for the Prevention of Recurrent Clostridium Difficile Infection Vancomycin, Placebos - Clostridium Difficile Infection	Phase 3	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	263	2020-11-19	2025-12-10
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea Clostridium Difficile Infection		Unknown	Hanyang University Seoul Hospital	500	2020-10-01	2020-09-28
ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection Ibezapolstat, Vancomycin - Clostridium Difficile Infection	Phase 2	Completed	Acurx Pharmaceuticals Inc.	53	2020-03-06	2025-01-17
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection No Intervention - Clostridium Difficile, Clostridium Difficile Infection		Withdrawn	ProgenaBiome		2020-03-02	2025-06-05
PROSPECTIVE STUDY OF PREDISPOSING FACTORS OF REFRACTARY Clostridium Difficile INFECTION. INFLUENCE OF THE GUT MICROBIOMA microbiome analysis - Clostridium Difficile Infection		Unknown	Hospital Universitario de Cabuenes	50	2020-03-01	2020-02-07
Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection Bezlotoxumab, Standard CDI treatment - Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence		Completed	University of Illinois at Chicago	180	2020-02-12	2023-02-28
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI Bezlotoxumab, Placebo, Fecal Microbiota Transplantation - Inflammatory Bowel Diseases, Clostridium Difficile Infection	Phase 2	Completed	Brigham and Women's Hospital	61	2020-01-01	2025-12-09
The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection Fecal microbiota transplantation - Clostridium Difficile Infection, Fecal Microbiota Transplantation	Not applicable	Completed	Shanghai 10th People's Hospital	60	2020-01-01	2024-01-12

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Narrower conditions

Clostridium Infections (132)  ·  Diarrhea (19)  ·  Enterocolitis, Pseudomembranous (7)  ·  Cross Infection (5)  ·  Infections (5)  ·  Recurrence (4)  ·  Colitis, Ulcerative (3)  ·  Gastrointestinal Diseases (3)  ·  Bacterial Infections (2)  ·  Colitis (2)  ·  Communicable Diseases (2)  ·  Crohn Disease (2)  ·  Diabetes Insipidus, Neurogenic (2)  ·  Gastroenteritis (2)  ·  Hepatic Encephalopathy (2)

Broader conditions

Bacterial Infections and Mycoses (132)  ·  Gram-Positive Bacterial Infections (131)  ·  Bacterial Infections (130)  ·  Infections (127)  ·  Pathological Conditions, Signs and Symptoms (32)  ·  Signs and Symptoms (20)  ·  Signs and Symptoms, Digestive (19)  ·  Pathologic Processes (16)  ·  Digestive System Diseases (14)  ·  Disease Attributes (13)  ·  Gastrointestinal Diseases (12)  ·  Intestinal Diseases (12)  ·  Gastroenteritis (11)  ·  Enterocolitis (6)  ·  Colonic Diseases (5)

Interventions

Vancomycin (31)  ·  Fecal Microbiota Transplantation (22)  ·  Fidaxomicin (8)  ·  bezlotoxumab (6)  ·  cadazolid (5)  ·  Saline Solution (4)  ·  CB-183,315 (3)  ·  Adjuvants, Pharmaceutic (2)  ·  Metronidazole (2)  ·  Omeprazole (2)  ·  alanylglutamine (2)  ·  ridinilazole (2)  ·  Anti-Bacterial Agents (1)  ·  Anti-Infective Agents (1)  ·  Antimicrobial Stewardship (1)

Sponsors

Actelion (5)  ·  Sanofi Pasteur, a Sanofi Company (4)  ·  University of Wisconsin, Madison (4)  ·  Chinese University of Hong Kong (3)  ·  Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (3)  ·  Medical College of Wisconsin (3)  ·  Merck Sharp & Dohme LLC (3)  ·  Brigham and Women's Hospital (2)  ·  Endeavor Health (2)  ·  Massachusetts General Hospital (2)  ·  Mayo Clinic (2)  ·  McMaster University (2)  ·  National Institute of Allergy and Infectious Diseases (NIAID) (2)  ·  Oslo University Hospital (2)  ·  Rebiotix Inc. (2)

Countries

United States (66)  ·  Canada (22)  ·  United Kingdom (10)  ·  Germany (9)  ·  Spain (8)  ·  Hungary (6)  ·  Denmark (5)  ·  France (5)  ·  Czechia (4)  ·  Japan (4)  ·  Poland (4)  ·  Sweden (4)  ·  Belgium (3)  ·  Bulgaria (3)  ·  China (3)

Top investigators

Nasia Safdar, MD PhD (3)  ·  Anne Claire Marrast, MD (2)  ·  Colleen Kelly, MD (2)  ·  Silvia Munoz-Price, M.D., Ph.D. (2)  ·  Aasma Shaukat, MD MPH (1)  ·  Abdulhadi Quadri, MD (1)  ·  Aida Jawhari, MD (1)  ·  Alison Mackie, MSc (1)  ·  Andrea Ayad, Dr. (1)  ·  Andreas M Petersen (1)  ·  Andrew Maternowski, MD (1)

Results publications

PMID 24762631, PMID 28121498, PMID 29538686, PMID 29680101, PMID 29788418, PMID 30060024, PMID 30227108, PMID 30455246, PMID 30460321, PMID 30709665, PMID 31411386, PMID 31628838, PMID 32099847, PMID 32376702, PMID 32504314, PMID 32747931, PMID 36661328, PMID 41245385, PMID 42286373, PMID 24467987, PMID 25942722, PMID 26248357, PMID 26348734, PMID 26419191, PMID 26433782, PMID 26592763, PMID 26757463, PMID 27013431, PMID 27079932, PMID 27316794, PMID 27432604, PMID 27558181, PMID 27707993, PMID 27943501, PMID 28461207, PMID 28480267, PMID 28539351, PMID 28961905, PMID 29116880, PMID 29385143, PMID 29718329, PMID 30254135, PMID 30610862, PMID 31537446, PMID 31685472, PMID 31846705, PMID 31883370, PMID 32101275, PMID 32191763, PMID 32946836

NIH funding

2015 (2), 2008 (1), 2016 (1), 2017 (1), P30CA046934 (1), U01AI150589 (1), U54CK000162 (1)