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

May 18, 2023 updated by: Dr Hegyi Péter, University of Pecs

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

238

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Pécs, Hungary, 7624
        • Institute for Translational Medicine, University of Pécs
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fecal filtrate transplantation
Patients randomized to the fecal filtrate transplantation group
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.
Active Comparator: Conventional fecal microbiota transplantation
Patients randomized to the conventional fecal microbiota transplantation group
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of diarrhea
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of diarrhea
Time Frame: 1 year
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
Recurrence of CDI symptoms
Time Frame: 8 weeks, 1 year
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
Overall mortality
Time Frame: 8 weeks, 1 year
Overall mortality. The rate of the outcome will be compared within groups.
8 weeks, 1 year
Disease associated mortality
Time Frame: 8 weeks, 1 year
Disease-associated mortality. The rate of the outcome will be compared within groups.
8 weeks, 1 year
Adverse events
Time Frame: 8 weeks, 1 year
Proportion of adverse events (AE) and serious adverse events (SAE). The rate of the outcome will be compared within groups.
8 weeks, 1 year
Change of the intestinal microbiome
Time Frame: 8 weeks, 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 10, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30700-5/2021/EÜIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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