Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection (NCT03353506) | Clinical Trial Compass
CompletedPhase 2
Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection
Canada11 participantsStarted 2018-02-14
Plain-language summary
Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.
Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).
Who can participate
Age range18 Years
SexALL
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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 toxin, each occurring within 3 months of each other.
✓. CDI 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 use effective contraception for the duration of the study as applicable
Exclusion criteria
✕. Complicated CDI defined as WBC \>35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure \<90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
✕. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
✕. Taking or planning to take an investigational drug within 3 months of enrollment.