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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Novel Faecal Microbiota Transplantation System for Treatment of Primary and Recurrent Clostridium Difficile Infection

NCT03053505

Clostridium Difficile Infection

UNKNOWN NA

Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

NCT03353506

Enterocolitis Recurrent Clostridium Difficile Infection

COMPLETED PHASE2

Fecal Microbiome Transplant

NCT02636517

Clostridium Difficile Inflammatory Bowel Disease Crohn's Disease +1 more

ENROLLING_BY_INVITATION PHASE1

Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

NCT03806803

Clostridia Difficile Colitis Clostridium Difficile Diarrhea

COMPLETED PHASE2

Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection

NCT03427229

Clostridium Difficile Pseudomembranous Colitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clostridium Difficile Infection Recurrent Clostridium Difficile Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fecal filtrate transplantation

Patients randomized to the fecal filtrate transplantation group

Group Type ACTIVE_COMPARATOR

Fecal filtrate transplantation

Intervention Type BIOLOGICAL

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 randomized to the conventional fecal microbiota transplantation group

Group Type ACTIVE_COMPARATOR

Conventional fecal microbiota transplantation

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No