FMT Capsules for rCDI (FMT CAP CDI)

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

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

Study Overview

• Status: Recruiting
• Conditions: FMT; Clostridioides Difficile Infection Recurrence
• Intervention / Treatment: Biological: Healthy donor stool; Biological: placebo capsule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Perttu Arkkila, Professor; Phone Number: +35894711 +358504272272; Email: perttu.arkkila@hus.fi
• Study Contact Backup: Name: Suvi Niku, PhD, MD; Phone Number: +35894711 +35840 7579938; Email: suvi.niku@hus.fi

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00290
      • Recruiting
      • Helsinki university hospital
      • Contact: Perttu Arkkila, Professor; Phone Number: +35894711 +358504272272; Email: perttu.arkkila@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving active treatment; CDI patients receiving healthy donor stool by capsules	Biological: Healthy donor stool; Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital; Other Names: FMT; Fecal microbiota transplantation
Placebo Comparator: Placebo arm; Placebo FMT capsules	Biological: placebo capsule; Copenhagen University Hvidrovre Hospital method for capsule production; Other Names: Placebo FMT capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement.	The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with side effects after FMT capsules.	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.	One, four and twelve weeks after FMT (placebo or active FMT).

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Perttu Arkkila, Professor, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: FMT; Capsule; Clostridioides Difficile infection
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: 00290; TYH2025304 (Other Grant/Funding Number: Finnish state research funding)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators have no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No