Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection
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|ClinicalTrials.gov Identifier: NCT03353506|
Recruitment Status : Active, not recruiting
First Posted : November 27, 2017
Last Update Posted : March 26, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Enterocolitis Recurrent Clostridium Difficile Infection||Biological: LFMT Biological: LSFF||Phase 2|
This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.
Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double blind randomized|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||LFMT and LSFF capsules appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care|
|Official Title:||A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)|
|Actual Study Start Date :||February 14, 2018|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||January 15, 2023|
Active Comparator: LFMT
Lyophilized fecal microbiota transplant capsules
Lyophilized fecal microbiota transplant
Lyophilized sterile fecal filtrate capsules
Lyophilized sterile fecal filtrate
- Resolution of RCDI [ Time Frame: 8 weeks ]Proportion of subjects without RCDI
- Resolution of RCDI [ Time Frame: 24 weeks ]Proportion of subjects with sustained cure
- Serious Adverse Events [ Time Frame: 8 weeks ]Mortality directly attributable to CDI or treatment
- Serious Adverse Events [ Time Frame: 8 weeks ]Infection directly attributable to treatment
- Minor Adverse Events [ Time Frame: 1 week ]nausea
- Minor Adverse Events [ Time Frame: 1 week ]vomiting
- Minor Adverse Events [ Time Frame: 1 week ]abdominal pain
- Difficulty in swallowing capsules [ Time Frame: 1 week ]Reported by subjects as ranging between none, moderate or severe
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353506
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2X8|
|Principal Investigator:||Dina Kao, MD||University of Alberta|