Clostridium Butyricum in Stenosing Crohn's Disease
Phase 1 / Phase 2 · Testing Clostridum Butyricum Capsule and Trehalose · 1 site · San Giovanni Addolorata Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Clostridum Butyricum Capsule (a dietary supplement) and Trehalose (a dietary supplement) to better understand how the disease works. Condition(s) listed: Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 85
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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.
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-05-08.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Efficacy of C. butyricum in stimulating autophagy (2 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | San Giovanni Addolorata Hospital |
| Collaborators | University of Roma La Sapienza |
| Enrollment | 40 (estimated) |
| Start date | 2026-05-08 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2025-12-04 |
| Last updated | 2026-09-04 |
| Official title | Efficacy and Safety of Therapeutic Application of Clostridium Butyricum in Patiens With Stenosing Crohn's Disease: a Pilot Study |
| ClinicalTrials.gov ID | NCT07263880 |
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
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| San Giovanni Addolorata Hospital | Roma | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.