FMT Capsules for rCDI (FMT CAP CDI)

Helsinki University Central Hospital (HUCH)

Status and phase: Not yet enrolling; Phase 3

Conditions: FMT; Clostridioides Difficile Infection Recurrence

Treatments: Biological: placebo capsule; Biological: Healthy donor stool

Study type: Interventional

Funder types: Other

Identifiers

NCT07458984

TYH2025304 (Other Grant/Funding Number)

00290

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

Patients receiving active treatment

Experimental group

Description:

CDI patients receiving healthy donor stool by capsules

Treatment:

Biological: Healthy donor stool

Placebo arm

Placebo Comparator group

Description:

Placebo FMT capsules

Treatment:

Biological: placebo capsule