Clostridium Difficile Infection Clinical Trial
— FILTRATEOfficial title:
Fecal Filtrate Versus Conventional Microbiota Transplantation in the Treatment of Multiple Recurrent Clostridioides Difficile Infection (FILTRATE): A Protocol of a Randomized, Controlled Trial
Clostridioides difficile infection (CDI) is one of the most common hospital-acquired infectious diseases with a high mortality rate (6-30%). The treatment of CDI, especially the recurrent form of the disease is still considered a challenge. The FILTRATE randomized controlled trial aims to investigate the safety and efficacy of fecal filtrate transplantation in the treatment of recurrent CDI and compare it with conventional fecal microbiota transplantation (FMT).
Status | Not yet recruiting |
Enrollment | 238 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age =18 years - multiple recurrent CDI (=2 previous episodes of CDI) - at least 3 or more loose or watery stools (Bristol 5-7) per day - a positive Glutamate Dehydrogenase (GDH)-enzyme and positive CDI toxin A and/or B test - the patient or the legal guardian sign the written informed consent Exclusion Criteria: - pregnancy or breastfeeding - ongoing antibiotic treatment - fulminant CDI - previous FMT - immunodeficiency - need of intensive care - requirement for vasoactive drugs - other cause of diarrhea - inflammatory bowel diseases - irritable bowel syndrome - life expectancy shorter than 3 months - unavailable for follow-up visits |
Country | Name | City | State |
---|---|---|---|
Hungary | Institute for Translational Medicine, University of Pécs | Pécs |
Lead Sponsor | Collaborator |
---|---|
University of Pecs |
Hungary,
Dembrovszky F, Gede N, Szakacs Z, Hegyi P, Kiss S, Farkas N, Molnar Z, Imrei M, Dohos D, Peterfi Z. Fecal Microbiota Transplantation May Be the Best Option in Treating Multiple Clostridioides difficile Infection: A Network Meta-Analysis. Infect Dis Ther. — View Citation
Varga A, Kocsis B, Sipos D, Kasa P, Vigvari S, Pal S, Dembrovszky F, Farkas K, Peterfi Z. How to Apply FMT More Effectively, Conveniently and Flexible - A Comparison of FMT Methods. Front Cell Infect Microbiol. 2021 Jun 4;11:657320. doi: 10.3389/fcimb.202 — View Citation
Youngster I, Sauk J, Pindar C, Wilson RG, Kaplan JL, Smith MB, Alm EJ, Gevers D, Russell GH, Hohmann EL. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, con — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of diarrhea | Clinical resolution of the CDI associated diarrhea, defined by 2 or less stools (Bristol 1-4) per day in two consecutive days. The rate of the outcome will be compared within groups. | 8 weeks | |
Secondary | Resolution of diarrhea | Clinical resolution of the CDI associated diarrhea, defined by 2 or less stools (Bristol 1-4) per day in two consecutive days. The rate of the outcome will be compared within groups. | 1 year | |
Secondary | Recurrence of CDI symptoms | Recurrence of the CDI symptoms (diarrhea, abdominal pain ect.) within 8 weeks after an initial amelioration. The rate of the outcome will be compared within groups. | 8 weeks, 1 year | |
Secondary | Overall mortality | Overall mortality. The rate of the outcome will be compared within groups. | 8 weeks, 1 year | |
Secondary | Disease associated mortality | Disease-associated mortality. The rate of the outcome will be compared within groups. | 8 weeks, 1 year | |
Secondary | Adverse events | Proportion of adverse events (AE) and serious adverse events (SAE). The rate of the outcome will be compared within groups. | 8 weeks, 1 year | |
Secondary | Change of the intestinal microbiome | Change of the intestinal microbiome at the end of the follow up period regarding to the initial intestinal microbiome. The rate of the outcome will be compared within groups. | 8 weeks, 1 year |
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