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โ† Trials
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Clostridium Butyricum in Stenosing Crohn's Disease

RecruitingPhase 1, Phase 2Ages 18 Years - 85 YearsAllSan Giovanni Addolorata Hospital
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In plain words

What the trial is, and whether it could suit you

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 possibi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ18 and โ‰ค85 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-TNFฮฑ, 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.
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What it tests

  • Clostridum Butyricum Capsule
  • Trehalose
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Where

1 site
San Giovanni Addolorata Hospital
Roma, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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