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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04960306
Other study ID # 30700-5/2021/EÜIG
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2023
Est. completion date December 1, 2025

Study information

Verified date May 2023
Source University of Pecs
Contact Péter Hegyi, MD,PhD, Dsc
Phone +3672/536-246
Email p.hegyi@tm-centre.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

The treatment of recurrent CDI is still a burden on the healthcare system. FMT is highly effective for the treatment of recurrent CDI, resulting in the resolution of CDI up to 100% of the cases. FMT also has a good short-term safety profile, however long-term events like transfer of multiresistant bacteria and other living microorganism is still a major problem. On the other hand, the fecal filtrate contains only bacterial debris, proteins, and antimicrobial compounds and not intact microorganisms. The FILTRATE trial is a multicenter, two-arm randomized controlled trial, and aims to compare the safety and efficacy of fecal filtrate transplantation to conventional fecal microbiota transplantation (FMT) in the treatment of recurrent CDI. Adult patients with multiple recurrent (>1) CDIs will be randomized 1:1 to receive either FMT or fecal filtrate transplantation. The transplantation will be carried out using lyophilized capsule on each arm. The primary endpoint of the study will be the clinical resolution of CDI-associated diarrhea 8 weeks after the interventions. Questionnaires will be completed on enrollment and at the time of each follow-up. Adverse events will be recorded and reported to the relevant institutional and national ethics committee. After the intervention, a one-year follow-up is also planned. Blood and stool samples will be collected at baseline and at each follow-up.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Fecal filtrate transplantation
Patients will receive 5-8 encapsulated lyophilized fecal filtrate transplantations in enterosolvent, size "0" capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules.
Conventional fecal microbiota transplantation
Patients will receive 5-8 encapsulated lyophilized conventional fecal microbiota transplantations in enterosolvent, size "0" capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules.

Locations

Country Name City State
Hungary Institute for Translational Medicine, University of Pécs Pécs

Sponsors (1)

Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (3)

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

Outcome

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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