Butyricum probiotic to help with Crohn’s disease with stricturing

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 pilot interventional trial enrolling 40 adults with Crohn’s disease and a stricturing (B2) phenotype. Participants will be randomized to receive Clostridium butyricum capsules, trehalose, or a combination arm for two months prior to a planned colonoscopy to assess tolerability and potential effects on autophagy-related pathways. The study focuses on patients with disease localized to the right colon or ileocecal region and not on intensive immunomodulatory therapy. Outcomes will inform whether modulating autophagy via a next-generation probiotic or an autophagy inducer could influence fibrostenotic processes. The trial is conducted at San Giovanni Addolorata Hospital in collaboration with the University of Rome La Sapienza.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patients with a confirmed diagnosis of Crohn's disease (established according to clinical, endoscopic, histological, and radiological criteria in line with current Italian and European guidelines), with a stricturing phenotype (B2 according to the Montreal classification), determined based on the patient's clinical history and instrumental examinations, with disease localized to the right colon or ileocecal region, followed at the Inflammatory Bowel Disease Outpatient Clinic of the Gastroenterology and Digestive Endoscopy Unit, in whom a colonoscopy with biopsies has been scheduled for clinical indication (disease reassessment, flare-up, or follow-up).
* Patients aged ≥18 and ≤85 years.
* Patients either not receiving any specific immunomodulatory therapy for Crohn's disease or undergoing treatment with mesalazine or sulfasalazine.
* Patients who have been adequately informed about the study protocol and who have understood and voluntarily signed the informed consent form.

Exclusion Criteria:

* Other acute or chronic inflammatory bowel diseases (e.g., diverticulitis, infectious colitis, ulcerative colitis).
* Patients receiving treatment for Crohn's disease with immunosuppressive drugs (thiopurines, methotrexate, cyclosporine), biologics (anti-TNFα, vedolizumab, ustekinumab), oral antiJAK or oral/intravenous corticosteroids.
* Immunological or rheumatologic diseases.
* Current or past malignancies.
* Active infections.
* History of organ transplantation.
* Current treatments with pharmacological agents known to significantly modulate the autophagic process.

Where it's running

• San Giovanni Addolorata Hospital
  Roma, Italy Recruiting

Study contacts

• Study coordinator: Cristiano Pagnini, MD, PhD
• Email: cpagnini@hsangiovanni.roma.it
• Phone: +39 06 7705 1

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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.