Clinical Trials Logo

Clinical Trial Summary

Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works. Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups. Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.


Clinical Trial Description

This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules. Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03806803
Study type Interventional
Source University of Alberta
Contact
Status Completed
Phase Phase 2
Start date March 21, 2019
Completion date March 12, 2024

See also
  Status Clinical Trial Phase
Completed NCT00382304 - A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea Phase 2
Recruiting NCT04246151 - Oral Vancomycin Versus Probiotics Versus Placebo for Prevention of Clostridium Difficile Infection in Colonized Patients Early Phase 1
Terminated NCT00772954 - Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity Phase 1
Recruiting NCT04305769 - Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Phase 2
Completed NCT00034294 - A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea Phase 2
Terminated NCT03793686 - A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea Phase 1
Recruiting NCT02200328 - Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients Phase 4
Recruiting NCT03141775 - Incidence and Economic Burden of Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS) N/A