FMT Capsules for rCDI

NCT07458984 | Recruiting Phase 3

• 2 other identifiers: 00290TYH2025304
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Clostridioides Difficile Infection Recurrence; FMT

Keywords

Clostridioides Difficile infection; FMT; Capsule

Outcome Measures

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.

  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 Outcomes (1)

• Number of patients with side effects after FMT capsules.

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

Study Arms (2)

Patients receiving active treatment

EXPERIMENTAL

CDI patients receiving healthy donor stool by capsules

Biological: Healthy donor stool

Placebo arm

PLACEBO COMPARATOR

Placebo FMT capsules

Biological: placebo capsule

Interventions

Healthy donor stool BIOLOGICAL

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

Also known as: Fecal microbiota transplantation, FMT

Patients receiving active treatment

placebo capsule BIOLOGICAL

Copenhagen University Hvidrovre Hospital method for capsule production

Also known as: Placebo FMT capsules

Placebo arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00290, Finland

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Perttu Arkkila, Professor

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perttu Arkkila, Professor

CONTACT

+358504272272; perttu.arkkila@hus.fi

Suvi Niku, PhD, MD

CONTACT

+35840 7579938; suvi.niku@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 9, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)