FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

• Sponsor: University of Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT02254811
• Collaborator: University of Calgary (Other)
• Enrollment: 116
• Locations: 2
• Arms: 2
• Actual Duration (Months): 35.8
• Patients Per Site: 58
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Enterocolitis Clostridium Difficile Recurrent	Biological: Fecal Microbiota Transplant	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)
• Actual Study Start Date: Sep 18, 2014
• Actual Primary Completion Date: Dec 12, 2016
• Actual Study Completion Date: Sep 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Delivery via capsule Fecal microbiota transplant is delivered by oral capsules	Biological: Fecal Microbiota Transplant; transfer of healthy human gut bacteria to restore the microbiome
Experimental: Delivery via colonoscopy Fecal microbiota transplant delivered by colonoscopy	Biological: Fecal Microbiota Transplant; transfer of healthy human gut bacteria to restore the microbiome

Outcome Measures

Primary Outcome Measures

1. Proportion of patients without recurrent CDI [12 weeks after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foothills Hospital	Calgary	Alberta	Canada	T2N 2T9
2	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2X8

Sponsors and Collaborators

• University of Alberta
• University of Calgary

Investigators

• Principal Investigator: Dina Kao, MD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dina Kao, Associate Professor, University of Alberta
• ClinicalTrials.gov Identifier: NCT02254811
• Other Study ID Numbers: 48233
• First Posted: Oct 2, 2014
• Last Update Posted: Oct 24, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Enterocolitis; Recurrence

Study Results

No Results Posted as of Oct 24, 2019