RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Clostridium Butyricum in Stenosing Crohn's Disease

Sponsor: San Giovanni Addolorata Hospital • ClinicalTrials.gov ID: NCT07263880

Registry updated: 2026-09-04

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Description

Crohn's disease is a condition of unknown etiology with an immune-mediated pathogenesis. The subgroup of Crohn's disease with a stricturing phenotype represents a particular challenge for clinicians, as currently no effective medical therapies are available for the prevention or treatment of fibrosis. Autophagy is a key mechanism in the regulation of cellular homeostasis, and preliminary reports from our group and others have suggested a potential role in the pathogenesis of fibrostenotic complications in Crohn's disease. The next-generation probiotic Clostridium butyricum has recently been proposed as a treatment option in several conditions, including inflammatory bowel diseases (IBD). Its beneficial effects are mainly exerted through the production of butyric acid, which in turn plays important roles at the intestinal mucosal level, including the stimulation of autophagy. The possibility of stimulating autophagy in patients with stricturing Crohn's disease may represent a promising therapeutic approach for the prevention and treatment of fibrosis. This study involves the collection of biopsy and blood samples from 40 patients with stricturing Crohn's disease undergoing colonoscopy. In the two months preceding colonoscopy, patients will be randomized into four groups: Patients treated with C. butyricum Patients treated with the autophagy stimulator trehalose Patients treated with C. butyricum + trehalose Patients treated with placebo Laboratory analyses will be performed on biopsy and blood samples to evaluate and quantify molecular mediators involved in inflammation, fibrosis, and autophagy.

Interventions

Clostridum Butyricum Capsule (Dietary supplement)
Administration of C. butyricum tablets (3 + 3 per day, 27 x 10\^5 CFY/day)
Trehalose (Dietary supplement)
Administration of trehalose at 30 g per day

Eligibility criteria

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.

Conditions

Crohn Disease (CD)

Locations

San Giovanni Addolorata Hospital — Roma, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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