FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff

Enterocolitis Clostridium Difficile Recurrent Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254811
• Other study ID #: 48233
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 18, 2014
• Est. completion date: September 13, 2017

Study information

• Verified date: October 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 13, 2017
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis Clostridium Difficile Recurrent

Intervention

Biological:
• Fecal Microbiota Transplant
transfer of healthy human gut bacteria to restore the microbiome

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients without recurrent CDI		12 weeks after treatment