Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

  • STATUS
    Recruiting
  • End date
    Mar 6, 2023
  • participants needed
    248
  • sponsor
    University of Alberta
Updated on 10 February 2022
antibiotic therapy
antibiotics
microbiota
fecal microbiota transplantation
clostridium difficile

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.

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.

Details
Condition Clostridia Difficile Colitis, Clostridium Difficile Diarrhea
Treatment Lyophilized fecal microbiota transplant, Lyophilized sterile fecal filtrate
Clinical Study IdentifierNCT03806803
SponsorUniversity of Alberta
Last Modified on10 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other
CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
Ability to provide informed consent
Females and males must agree to effective contraception for the duration of the study

Exclusion Criteria

Severe or fulminant colitis
Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment
Chemotherapy or radiation therapy
Those taking or planning to take an investigational drug within 3 months of enrollment
Oropharyngeal or significant esophageal dysphagia
Ileus or small bowel obstruction
Pregnant or planning to become pregnant within 3 months
Breastfeeding or planning to breastfeed during the trial
Active infection requiring antibiotics
Life expectancy <6 months Those with history of total colectomy
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