FMT Capsules for rCDI

Phase 3Not Yet RecruitingNCT07458984

Helsinki University Central Hospital76 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Clostridioides Difficile Infection Recurrence FMT

Interventions

Healthy donor stoolBIOLOGICAL

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

placebo capsuleBIOLOGICAL

Copenhagen University Hvidrovre Hospital method for capsule production

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

Central Contacts

Perttu Arkkila, Professor

CONTACT

+358504272272 perttu.arkkila@hus.fi

Suvi Niku, PhD, MD

CONTACT

+35840 7579938 suvi.niku@hus.fi

Data from ClinicalTrials.gov

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