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

NCT01372943 | Terminated

• 1 other identifier: DMED 1318-10
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Clostridium difficile; recurrent; infection

Outcome Measures

Primary Outcomes (1)

• number of participants cured of CDI

  6 months

Study Arms (1)

synthetic stool

EXPERIMENTAL

"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

Biological: "synthetic stool" or pure cultures of probiotic intestinal bacteria

Interventions

"synthetic stool" or pure cultures of probiotic intestinal bacteria 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

synthetic stool

Eligibility Criteria

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

You may qualify if:

• patients with recurrent CDI that have failed standard therapy

You may not qualify if:

• critically ill patients

Sponsors & Collaborators

• Queen's University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Related Publications (1)

• 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.

  PMID: 24467987 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Recurrence; Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Petrof, MD

  Kingston Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 14, 2011
• Study Start: January 1, 2010
• Primary Completion: January 1, 2017
• Study Completion: August 31, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

CA (1)