FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-18

Study Completion Date

2017-09-13

Brief Summary

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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%.

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Detailed Description

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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.

Conditions

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Enterocolitis Clostridium Difficile Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delivery via capsule

Fecal microbiota transplant is delivered by oral capsules

Group Type EXPERIMENTAL

Fecal Microbiota Transplant

Intervention Type BIOLOGICAL

transfer of healthy human gut bacteria to restore the microbiome

Delivery via colonoscopy

Fecal microbiota transplant delivered by colonoscopy

Group Type EXPERIMENTAL

Fecal Microbiota Transplant

Intervention Type BIOLOGICAL

transfer of healthy human gut bacteria to restore the microbiome

Interventions

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Fecal Microbiota Transplant

transfer of healthy human gut bacteria to restore the microbiome

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No