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

NCT04960306 | Unknown Phase 3 DMC

• 1 other identifier: 30700-5/2021/EÜIG
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Clostridium Difficile Infection; Recurrent Clostridium Difficile Infection

Keywords

fecal microbiota transplantation; fecal filtrate; recurrent infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Resolution of diarrhea

  1 year

• Recurrence of CDI symptoms

  8 weeks, 1 year

• Overall mortality

  8 weeks, 1 year

• Disease associated mortality

  8 weeks, 1 year

• Adverse events

  8 weeks, 1 year

Study Arms (2)

Fecal filtrate transplantation

ACTIVE COMPARATOR

Patients randomized to the fecal filtrate transplantation group

Biological: Fecal filtrate transplantation

Conventional fecal microbiota transplantation

ACTIVE COMPARATOR

Patients randomized to the conventional fecal microbiota transplantation group

Biological: Conventional fecal microbiota transplantation

Interventions

Fecal filtrate transplantation 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.

Fecal filtrate transplantation

Conventional fecal microbiota transplantation 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.

Conventional fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

Location

Related Publications (3)

• 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.2021.657320. eCollection 2021.

  PMID: 34150673 RESULT

• 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. 2021 Mar;10(1):201-211. doi: 10.1007/s40121-020-00356-9. Epub 2020 Oct 26.

  PMID: 33106983 RESULT

• 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, controlled pilot study. Clin Infect Dis. 2014 Jun;58(11):1515-22. doi: 10.1093/cid/ciu135. Epub 2014 Apr 23.

  PMID: 24762631 RESULT

Related Links

• Related info

MeSH Terms

Conditions

Clostridium Infections; Reinfection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Péter Hegyi, MD,PhD, Dsc

CONTACT

+3672/536-246; p.hegyi@tm-centre.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 13, 2021
• Study Start: November 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

HU (1)