Crofelemer for Functional Diarrhea
NCT04486326 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2026-03-10
Summary
The primary objectives of this study are to evaluate the clinical response of patients with diarrhea to crofelemer relative to placebo and evaluate the overall safety and tolerability of crofelemer in the treatment of diarrhea.
Conditions
Interventions
- DRUG
-
Crofelemer
Crofelemer
- DRUG
-
placebo
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Anthony Lembo, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-20
- Primary Completion
- 2022-09-23
- Completion
- 2022-09-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
NCT03045926 ·Status: COMPLETED ·Phase: PHASE1
-
Defined Fecal Microbiota Transplantation for Clostridium Difficile Diarrhea
NCT01868373 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
NCT03562741 ·Status: RECRUITING ·Phase: NA
-
Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection
NCT02053350 ·Status: TERMINATED ·Phase: PHASE2
-
Cholera Anti-Secretory Treatment Trial
NCT04150250 ·Status: COMPLETED ·Phase: PHASE2
-
Response of Clostridium Difficile Infection to Metronidazole Therapy
NCT00304369 ·Status: COMPLETED
-
Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection
NCT02326636 ·Status: COMPLETED
-
Stool Transplant in Pediatric Patients With Recurring C. Difficile Infection
NCT01972334 ·Status: COMPLETED ·Phase: PHASE2
-
SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence
NCT02830542 ·Status: COMPLETED ·Phase: PHASE1
-
Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route
NCT02449174 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Placebo Controlled Study of Fecal Microbiota Transplant (FMT) for a First or Second Episode of C. Difficile Infection in Adults Using a Frozen Encapsulated Inoculum
NCT02343328 ·Status: TERMINATED ·Phase: PHASE1
-
Transplantation of Fecal Microbiota for Clostridium Difficile Infection
NCT01958463 ·Status: UNKNOWN ·Phase: PHASE3
-
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
NCT01259726 ·Status: COMPLETED ·Phase: PHASE2
-
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
NCT02318992 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
NCT00747071 ·Status: WITHDRAWN ·Phase: PHASE2/PHASE3
-
Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease
NCT03998423 ·Status: TERMINATED ·Phase: PHASE1
-
Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea
NCT00304876 ·Status: COMPLETED
-
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
NCT03756454 ·Status: TERMINATED ·Phase: PHASE4
-
Open-Label "Compassionate" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients
NCT00002062 ·Status: COMPLETED ·Phase: NA
-
Host Immune Response to Clostridium Difficile Infection (ICD)
NCT02440438 ·Status: COMPLETED ·Phase: NA
-
A Flexible Clinical Trial to Test if Freeze-dried Fecal Microbiota Therapy Helps Treat Diarrhea-predominant Irritable Bowel Syndrome or Prevent Recurring C. Difficile Infections.
NCT06948461 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection
NCT02134392 ·Status: UNKNOWN ·Phase: PHASE1
-
Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis
NCT01959048 ·Status: TERMINATED ·Phase: NA
-
Stool Transplant to Control Treatment-related Diarrhea
NCT04883762 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD)
NCT00097422 ·Status: COMPLETED ·Phase: PHASE2