Oral donor fecal capsules for recurrent C. difficile infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized placebo-controlled Phase 3 trial enrolling 76 adults with at least two prior recurrences of Clostridioides difficile infection. Participants who are in remission on antibiotics are randomized to receive either donor stool capsules or placebo capsules and are followed for recurrence and safety outcomes. The trial also examines whether stool antigen tests or clinical risk-factor information can identify which patients benefit most from fecal transplantation. Standard exclusion criteria include pregnancy, ongoing need for antibiotics, gastroparesis, fulminant disease, or limited life expectancy.

Why it matters

Who can join: the full rules

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

Where it's running

• Helsinki University Hospital
  Helsinki, Uusimaa, Finland Recruiting

Study contacts

• Principal investigator: Perttu Arkkila, Professor — Helsinki University Central Hospital
• Study coordinator: Perttu Arkkila, Professor
• Email: perttu.arkkila@hus.fi
• Phone: +358504272272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Examining gut microbiota changes after fecal microbiota transplantation for recurrent Clostridioides difficile infection

  This study is testing how a fecal transplant from healthy donors affects the gut bacteria of people with recurring Clostridioides difficile infections.

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• Gut microbiome and physical performance: antibiotics and fecal transplants in healthy adults

  This study tests whether the gut microbiome affects physical abilities in healthy adults and whether antibiotics and fecal microbiota transplantation can change performance and metabolic responses.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.