A Phase 1/2 interventional study of Clostridum Butyricum Capsule and Trehalose in Crohn Disease (CD), sponsored by San Giovanni Addolorata Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by San Giovanni Addolorata Hospital · Phase 1/2, Interventional, and Basic science
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.
Crohn's disease is a chronic, relapsing inflammatory bowel disease with unknown etiology, involving immune dysregulation and microbiota alterations. Stricturing disease (Montreal B2 phenotype) represents a major unmet therapeutic need, as no pharmacological therapies are currently available for intestinal fibrosis, which is often managed surgically.
Autophagy, a key regulator of cellular homeostasis, has been linked to Crohn's disease pathogenesis, with genetic studies identifying polymorphisms in autophagy-related genes. Impaired autophagy may exacerbate inflammation, oxidative stress, and tissue damage. Preliminary data from our group show reduced autophagy in patients with stricturing Crohn's disease compared to those with inflammatory phenotype or healthy controls.
Clostridium butyricum, a next-generation probiotic with strong butyrate-producing activity, exerts anti-inflammatory and mucosal protective effects partly through stimulation of autophagy. Its use may represent a novel therapeutic approach to prevent or mitigate fibrostenotic complications in Crohn's disease.
This is a non-profit, interventional clinical pilot study enrolling 40 patients with stricturing Crohn's disease (B2, Montreal classification; localization L2 or L3). Patients undergoing clinically indicated colonoscopy will be randomized to one of four groups to receive for two months prior to the procedure:
The primary objective is to test the hypothesis that C. butyricum is safe and capable of stimulating local autophagic processes in the intestinal mucosa of patients with stricturing Crohn's disease.
Secondary objectives include evaluating autophagy-related pathways (inflammation, fibrosis, ROS production, NADPH oxidase activity) and comparing outcomes across the four treatment groups. Laboratory procedures will be used to evaluate and quantify, in bioptic and blood samples autophagy, inflammation, fibrosis, and oxidative stress.In particular, autophagy will be evaluated by measurement of the mucosal autophagic markers LC3b-II and p62. Inflammation will be evaluated by measuring the expression of pro-inflammatory cytokines (TNFα, IFNγ, IL-17, and COX2), quantifying mRNA by real-time (RT)- PCR with specific primers. Fibrosis will be evaluated by quantification of mRNA of the related genes Col1a1, α-sma, Snail1, Snail2, TGFβ. Finally, oxydative stress levels will be evaluated by measuring serum markers such as sNOX2-dp, H2O2, and serum hydrogen peroxide (H2O2) breakdown activity (HBA).
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →San Giovanni Addolorata Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clostridium butyricum CBM 588 (27 x 10\^5 CFU/day)
Dietary Supplement: Clostridum Butyricum Capsule
Threhalose (30g/day)
Dietary Supplement: Trehalose
C. butyricum (27 x 10\^5 CFU/day) + trehalose (30 g/day)
Dietary Supplement: Clostridum Butyricum Capsule · Dietary Supplement: Trehalose
Patients with no treatment
Administration of C. butyricum tablets (3 + 3 per day, 27 x 10\^5 CFY/day)
Administration of trehalose at 30 g per day
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
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
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
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
San Giovanni Addolorata Hospital