Clinical Trials Logo
  1. Home
  2. Clostridium Difficile Infection
  3. NCT01372943

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

Clostridium Difficile Infection Clinical Trial

Official title:
A Study Using "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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01372943
Study type Interventional
Source Queen's University
Contact
Status Terminated
Phase N/A
Start date January 2010
Completion date August 31, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT02214771 - Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients N/A
Withdrawn NCT01552668 - Fidaxomicin to Prevent Clostridium Difficile Colonization Phase 4
Recruiting NCT03325855 - Fecal Microbiota Transplant National Registry
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Suspended NCT03350711 - A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
Withdrawn NCT03643887 - Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients Phase 2
Terminated NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
Completed NCT03710694 - Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI) N/A
Completed NCT02865616 - MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI) Phase 1
Recruiting NCT04940468 - High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology N/A
Completed NCT02589847 - Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT02086916 - Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection N/A
Completed NCT01230957 - Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults Phase 2
Completed NCT01241552 - A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) Phase 3
Not yet recruiting NCT04567134 - Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Completed NCT04075422 - Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Recruiting NCT03712722 - Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Recruiting NCT05192148 - Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile N/A