FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Phase 2

Completed

• Conditions: Enterocolitis Clostridium Difficile Recurrent
• Interventions: Biological: Fecal Microbiota Transplant

• Registration Number: NCT02254811
• Lead Sponsor: University of Alberta

Brief Summary

Delivery of FMT by upper route, including gastroscopy, nasogastric/ nasojejunal tube, and lower route, including retention enema, sigmoidoscopy, or colonoscopy have all been utilized successfully. Endoscopic delivery requires significant health care utilization and associated cost. Therefore, it is extremely desirable if FMT can be infused by a non invasive modality, which would significantly reduce patient discomfort, procedure related risks and health care costs, while offering similar efficacy to colonoscopic delivery in the range of 90%.

Detailed Description

Patients with minimum 3 episodes of Clostridium difficile within 6 months are randomized 1:1 to received FMT by either colonoscopy or capsules. Pts are assessed at 1 week, 2 weeks, 1 mon, 3 mon, 6 mon and 1 year post FMT. Stool, urine and blood samples are collected. Medical cost for previous treatment is collected as well at pt perspective and QoL.

Study Timeline

• Study Start: 2014-09-18
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Primary Completion: 2016-12-12
• Study Completion: 2017-09-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Age > 18 and < 90 years at the time of Screening.
2. Diagnosis of at least 3 episodes of recurrent CDI, with each episode defined as presence of diarrhea (> 3 unformed stools/24 hours) associate with positive stool Clostridium difficle toxin, occurring within 3 months of each other.
3. CDI infection under symptomatic control with < 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure.
4. Those with ability to provide informed consent.

Exclusion Criteria

1. Those with complicated CDI, defined as white blood cell>35 or <0.5 x 109/L, significant abdominal pain and distension with evidence of toxic megacolon or pseudomembranous colitis, hypotension defined as systolic blood pressure < 90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring intensive care unit admission.
2. Those with chronic diarrheal illness, such as irritable bowel syndrome or inflammatory bowel disease unless they are in remission for at least 3 months prior to enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delivery via capsule	Fecal Microbiota Transplant	Fecal microbiota transplant is delivered by oral capsules
Delivery via colonoscopy	Fecal Microbiota Transplant	Fecal microbiota transplant delivered by colonoscopy

Primary Outcome Measures

Name	Time	Method
Proportion of patients without recurrent CDI	12 weeks after treatment

Trial Locations

Locations (2)

Foothills Hospital; 🇨🇦 Calgary, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada