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NCT Number: NCT07458984

FMT Capsules for rCDI

Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.

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Key information

Conditions

Clostridioides Difficile Infection Recurrence Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections FMT Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Helsinki University Hospital

Helsinki, Uusimaa, 00290, Finland

Location status: Recruiting

Location contact

Perttu Arkkila, Professor

CONTACT

[email protected]

+358504272272 ext. +35894711

About this study

The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least twice recurrent CDI*
  • Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools)
  • Other causes of diarrhea have been excluded based on clinical data
  • Age over 18 years
  • Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin)
  • No other antibiotic courses
  • Able to sign the consent form or accept it electronically via Suomi.fi identification
  • definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection

Exclusion criteria

  • Pregnancy
  • Continuous need for antibiotic treatment
  • Previous anaphylactic reactions to any food
  • Gastroparesis
  • Life-threatening fulminant CDI
  • Life expectancy less than 1 year
  • Inability to sign a consent form for the study

Treatment and study plan

Healthy donor stool

Biological

Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital

Other names: Fecal microbiota transplantation, FMT

placebo capsule

Biological

Copenhagen University Hvidrovre Hospital method for capsule production

Other names: Placebo FMT capsules

Primary outcomes

  1. Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT.

    Time frame: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).

    The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement.

Secondary outcomes

  1. Number of patients with side effects after FMT capsules.

    Time frame: One, four and twelve weeks after FMT (placebo or active FMT).

    Number of patients with side effects after FMT capsules. Number of Safety of FMT capsules is recorded by contacting the patient by phone call after 1 week and by answering the questionnaire after 1, 4 and 12 weeks after FMT (placebo or active FMT). Questionnaire includes information about any symptoms or signs possible related to recurrecy of CDI, such as fever (defined the temperature over 38 degrees), and diarrhea (defindes as more tahn three loose stool per day). Rate of side effects will be expressed by percentage of the patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Perttu Arkkila, Professor

CONTACT

[email protected]

+358504272272 ext. +35894711

Suvi Niku, PhD, MD

CONTACT

[email protected]

+35840 7579938 ext. +35894711

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection

Acronym: FMT CAP CDI

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 9, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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