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FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Primary Purpose

Enterocolitis Clostridium Difficile Recurrent

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Fecal Microbiota Transplant

About this trial

This is an interventional treatment trial for Enterocolitis Clostridium Difficile Recurrent

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Foothills Hospital
University of Alberta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Delivery via capsule

Delivery via colonoscopy

Arm Description

Fecal microbiota transplant is delivered by oral capsules

Fecal microbiota transplant delivered by colonoscopy

Outcomes

Primary Outcome Measures

Proportion of patients without recurrent CDI

Secondary Outcome Measures

Full Information

NCT ID

NCT02254811

First Posted

September 29, 2014

Last Updated

October 23, 2019

Sponsor

University of Alberta

Collaborators

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT02254811

Brief Title

FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 18, 2014 (Actual)

Primary Completion Date

December 12, 2016 (Actual)

Study Completion Date

September 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alberta

Collaborators

University of Calgary

4. Oversight

Data Monitoring Committee

Yes

5. 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%.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enterocolitis Clostridium Difficile Recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Delivery via capsule

Arm Type

Experimental

Arm Description

Fecal microbiota transplant is delivered by oral capsules

Arm Title

Delivery via colonoscopy

Arm Type

Experimental

Arm Description

Fecal microbiota transplant delivered by colonoscopy

Intervention Type

Biological

Intervention Name(s)

Fecal Microbiota Transplant

Intervention Description

transfer of healthy human gut bacteria to restore the microbiome

Primary Outcome Measure Information:

Title

Proportion of patients without recurrent CDI

Time Frame

12 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina Kao, MD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Foothills Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29183074

Citation

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.

Results Reference

derived

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FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

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