Clostridium Butyricum in Stenosing Crohn's Desease

NCT07263880 | Not Yet Recruiting Phase 1

• 1 other identifier: AUTOCD01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease (CD)

Keywords

Clostridium butyricum, autophagy

Outcome Measures

Primary Outcomes (2)

• Efficacy of C. butyricum in stimulating autophagy

  We evaluate the stimulation of autophagy measuring the mucosal expression and production of the molecular markers LC3 b II and p62 after treatment with C. butyricum

  2 months

• Safety of administration of C. butyricum

  Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] of C. butyricum in Crohn's disease patients will be evaluated by adverse event monitoring and reporting

  2 months

Secondary Outcomes (2)

• Treatment effect comparison

  2 months

• Oxydative stress measurement and comparation

  2 months

Study Arms (4)

C. butyricum

EXPERIMENTAL

Clostridium butyricum CBM 588 (27 x 10\^5 CFU/day)

Dietary Supplement: Clostridum Butyricum Capsule

Trehalose

ACTIVE COMPARATOR

Threhalose (30g/day)

Dietary Supplement: Trehalose

C butyricum + trehalose

EXPERIMENTAL

C. butyricum (27 x 10\^5 CFU/day) + trehalose (30 g/day)

Dietary Supplement: Clostridum Butyricum Capsule; Dietary Supplement: Trehalose

placebo

NO INTERVENTION

Patients with no treatment

Interventions

Clostridum Butyricum Capsule DIETARY_SUPPLEMENT

Administration of C. butyricum tablets (3 + 3 per day, 27 x 10\^5 CFY/day)

C butyricum + trehalose; C. butyricum

Trehalose DIETARY_SUPPLEMENT

Administration of trehalose at 30 g per day

C butyricum + trehalose; Trehalose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Giovanni Addolorata Hospital: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

San Giovanni Addolorata Hospital

Roma, 00184, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Trehalose

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Central Study Contacts

Cristiano Pagnini, MD, PhD

CONTACT

+39 06 7705 1; cpagnini@hsangiovanni.roma.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

IT (1)