Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection

Clostridium Difficile Infection Clinical Trial

— FILTRATE  

Official title:

Fecal Filtrate Versus Conventional Microbiota Transplantation in the Treatment of Multiple Recurrent Clostridioides Difficile Infection (FILTRATE): A Protocol of a Randomized, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04960306
• Other study ID #: 30700-5/2021/EÜIG
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence
• Recurrent Clostridium Difficile Infection

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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