Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
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|ClinicalTrials.gov Identifier: NCT03806803|
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridia Difficile Colitis Clostridium Difficile Diarrhea||Biological: Lyophilized fecal microbiota transplant Biological: Lyophilized sterile fecal filtrate||Phase 2|
This prospective double blind randomized study will enroll 110 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double blind randomized|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||LFMT and LSFF appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care.|
|Official Title:||A Multicenter Double Blind Randomized Study Comparing the Efficacy of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplantation (FMT) in the Management of Recurrent Clostridioides Difficile Infection (CDI)|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2023|
Active Comparator: LFMT
Lyophilized fecal microbiota transplant capsules
Biological: Lyophilized fecal microbiota transplant
Lyophilized sterile fecal filtrate capsules
Biological: Lyophilized sterile fecal filtrate
- Resolution of RCDI [ Time Frame: 8 weeks ]Proportion of patients without RCDI
- Resolution of RCDI [ Time Frame: 24 weeks ]Proportion of patients 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 discomfort
- Difficulty swallowing capsules [ Time Frame: 1 week ]Reported by patients as ranging between none, moderate or severe
- Fever [ Time Frame: 1 week ]Temperature of >37.8C
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): NCT03806803
|Contact: Dina Kao, MD||780 492 firstname.lastname@example.org|
|Principal Investigator:||Dina Kao, MD||University of Alberta|