Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Clostridium Difficile Clinical Trial

Official title:

Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02801656
• Other study ID #: MUN-02
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2022
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.

Description:

Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• life expectancy > 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization

Exclusion Criteria:

• pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received >4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count <200, or any medical or non-medical condition considered by the investigator to preclude participation.

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections
• Diarrhea

Intervention

Biological:
• Fecal Microbiota Transplantation
Oral, encapsulated FMT

Drug:
• Vancomycin
Vancomycin po 125 mg qid x 10 days

Biological:
• Fecal Microbiota Transplantation Placebo
Matching placebo to FMT

Drug:
• Vancomycin Placebo
Matching placebo to Vancomycin

Locations

Country	Name	City	State
Canada	Health Sciences Centre	St. John's	Newfoundland and Labrador

Sponsors (1)

Lead Sponsor	Collaborator
Memorial University of Newfoundland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Cure of diarrhea without recurrence in intention to treat population	Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.	56 days
Primary	Adverse Events	Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.	56 days
Secondary	Efficacy: Cure of diarrhea without recurrence in a per protocol population	Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.	56 days
Secondary	Efficacy: cure of diarrhea in intention to treat and per protocol populations	Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.	10 days
Secondary	Efficacy: time to cure of diarrhea	Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.	56 days
Secondary	Efficacy: Health status questionnaire		56 days