CompletedNCT02254811Updated Oct 24, 2019

FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

A Phase 2/3 interventional study of Fecal Microbiota Transplant in Enterocolitis Clostridium Difficile Recurrent, sponsored by University of Alberta. Completed at 2 sites in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-10-24.

Sponsored by University of Alberta · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 116
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study 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%.

Read the 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.

Conditions studied

Enterocolitis Clostridium Difficile Recurrent

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In context

Enterocolitis

216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.

This study's enrollment of 116 is above the median of 100 across 123 interventional studies indexed under Enterocolitis.

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Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age > 18 and \< 90 years at the time of Screening.
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.
CDI infection under symptomatic control with \< 3 loose/unformed BM's per 24 h period for at least 2 consecutive days before procedure.
Those with ability to provide informed consent.

Exclusion criteria

Exclusion Criteria:

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.
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

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 116 participants (actual)

Study arms

Experimental
Delivery via capsule
Fecal microbiota transplant is delivered by oral capsules
Biological: Fecal Microbiota Transplant
Experimental
Delivery via colonoscopy
Fecal microbiota transplant delivered by colonoscopy
Biological: Fecal Microbiota Transplant

Interventions

BiologicalFecal Microbiota Transplant
transfer of healthy human gut bacteria to restore the microbiome

What researchers measure

Primary outcomes

Proportion of patients without recurrent CDI
Time frame: 12 weeks after treatment

Study locations

2 sites

Foothills Hospital
Calgary, Alberta T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta T6G 2X8, Canada

References and documents

Publications

Kao D, Roach B, Silva M, Beck P, Rioux K, Kaplan GG, Chang HJ, Coward S, Goodman KJ, Xu H, Madsen K, Mason A, Wong GK, Jovel J, Patterson J, Louie T. Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2017 Nov 28;318(20):1985-1993. doi: 10.1001/jama.2017.17077. PubMed 29183074 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02254811
Lead sponsor: University of Alberta
Collaborators: University of Calgary
Responsible party: Dina Kao (Associate Professor, University of Alberta) — Principal investigator
First posted: Oct 2, 2014
Start date: Sep 18, 2014
Primary completion: Dec 12, 2016
Completion: Sep 13, 2017
Last update: Oct 24, 2019

Study contacts

Dina Kao, MD

principal investigator · University of Alberta

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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