FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

NCT02254811 | Completed Phase 2 DMC

• 1 other identifier: 48233
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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%.

Conditions

Enterocolitis Clostridium Difficile Recurrent

Outcome Measures

Primary Outcomes (1)

• Proportion of patients without recurrent CDI

  12 weeks after treatment

Study Arms (2)

Delivery via capsule

EXPERIMENTAL

Fecal microbiota transplant is delivered by oral capsules

Biological: Fecal Microbiota Transplant

Delivery via colonoscopy

EXPERIMENTAL

Fecal microbiota transplant delivered by colonoscopy

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

transfer of healthy human gut bacteria to restore the microbiome

Delivery via capsule; Delivery via colonoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (2)

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 29183074 DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Dina Kao, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 2, 2014
• Study Start: September 18, 2014
• Primary Completion: December 12, 2016
• Study Completion: September 13, 2017
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)