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Clostridium Butyricum in Stenosing Crohn's Disease

ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSan Giovanni Addolorata Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: C. butyricumExperimental treatment 1 intervention
Group B: TrehaloseActive comparator 1 intervention
Group C: C butyricum + trehaloseExperimental treatment 2 interventions
Group D: placeboNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 months
2

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

Time frame
2 months

Secondary outcomes

1

Treatment effect comparison

Comparation of the effect on autophagy induction (as mesured by LC3b-II and p62 mucosal production and expression), inflammatory (TNFα, IFNγ, IL-17 and COX2) and fibrosis (Col1a1, α-sma, Snail1, Snail2, TGFβ) markers in C. butyricum, trehalose, and C. butyricum+trehalose group

Time frame
2 months
2

Oxydative stress measurement and comparation

Measurement and comparation of serum oxydative stress markers (sNOX2-dp, H2O2, and serum hydrogen peroxide \[H2O2\] breakdown activity - HBA) in the groups

Time frame
2 months

Other outcomes

Sponsors and contacts

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San Giovanni Addolorata Hospital

Lead sponsor

University of Roma La Sapienza

Collaborator

Source ClinicalTrials.gov
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