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Clostridium Difficile InfectionPhase 3FILTRATENCT04960306

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

A Phase 3 study testing Fecal filtrate transplantation and Conventional fecal microbiota transplantation in people with Clostridium Difficile Infection and Recurrent Clostridium Difficile Infection, run by University of Pecs at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fecal filtrate transplantation and Conventional fecal microbiota transplantation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
1 siteHungary
Study dates
1 Nov 2023to 1 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • pregnancy or breastfeeding
  • ongoing antibiotic treatment
  • fulminant CDI
  • previous FMT
  • immunodeficiency
  • need of intensive care
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Péter Hegyi, MD,PhD, Dsc contact

+3672/536-246

p.hegyi@tm-centre.org

Hungary1 site

  • Institute for Translational Medicine, University of Pécs

    Pécs, 7624

    Péter Hegyi, MD,PhD, Dsc, p.hegyi@tm-centre.org

Other trials in Hungary

About this study

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

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).

Read the 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.

Being tested
Fecal filtrate transplantation, Conventional fecal microbiota transplantation
Keywords
fecal microbiota transplantation, fecal filtrate, recurrent infection
Medical subject headings
Clostridium Infections, Reinfection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal filtrate transplantationBiological

    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 transplantationBiological

    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.

Study groups in NCT04960306
Study groupRoleWhat they receive
Fecal filtrate transplantationActive comparatorPatients randomized to the fecal filtrate transplantation group
Receives: Biological: Fecal filtrate transplantation
Conventional fecal microbiota transplantationActive comparatorPatients randomized to the conventional fecal microbiota transplantation group
Receives: Biological: Conventional fecal microbiota transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks

Secondary outcomes (6)

  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.

    Measured: 1 year

  2. 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.

    Measured: 8 weeks, 1 year

  3. Overall mortality

    Overall mortality. The rate of the outcome will be compared within groups.

    Measured: 8 weeks, 1 year

  4. Disease associated mortality

    Disease-associated mortality. The rate of the outcome will be compared within groups.

    Measured: 8 weeks, 1 year

  5. Adverse events

    Proportion of adverse events (AE) and serious adverse events (SAE). The rate of the outcome will be compared within groups.

    Measured: 8 weeks, 1 year

  6. 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.

    Measured: 8 weeks, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2021
  2. Study start1 Nov 2023 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04960306
Sponsor's protocol ID
30700-5/2021/EÜIG
Acronym
FILTRATE
Status last verified
May 2023
First submitted
27 Jun 2021
Last updated
19 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34150673

  • 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.

    PubMed 33106983

  • 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.

    PubMed 24762631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fecal filtrate transplantation and Conventional fecal microbiota transplantation in people with Clostridium Difficile Infection and Recurrent Clostridium Difficile Infection, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Péter Hegyi, MD,PhD, Dsc (+3672/536-246, p.hegyi@tm-centre.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of diarrhea (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04960306, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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