CompletedPhase 2

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

Canada138 participantsStarted 2019-03-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Those taking or planning to take an investigational drug within 3 months of enrollment * Chemotherapy or radiation therapy * 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

What they're measuring

Resolution of RCDI

Timeframe: 8 weeks

Trial details

NCT IDNCT03806803

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-12