Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection

NCT ID: NCT01372943

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2018-08-31

Brief Summary

CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

synthetic stool

"synthetic stool" or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI

Group Type: EXPERIMENTAL

"synthetic stool" or pure cultures of probiotic intestinal bacteria

Intervention Type: BIOLOGICAL

"synthetic stool" or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI

Interventions

"synthetic stool" or pure cultures of probiotic intestinal bacteria

"synthetic stool" or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• patients with recurrent CDI that have failed standard therapy

Exclusion Criteria

• critically ill patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mark Ropeleski

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Petrof, MD

Role: PRINCIPAL_INVESTIGATOR

Kingston Health Sciences Centre

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

References

Petrof EO, Gloor GB, Vanner SJ, Weese SJ, Carter D, Daigneault MC, Brown EM, Schroeter K, Allen-Vercoe E. Stool substitute transplant therapy for the eradication of Clostridium difficile infection: 'RePOOPulating' the gut. Microbiome. 2013 Jan 9;1(1):3. doi: 10.1186/2049-2618-1-3.

Reference Type: DERIVED

PMID: 24467987 (View on PubMed)

Other Identifiers

DMED 1318-10

Identifier Type: -

Identifier Source: org_study_id