ClinicalTrials.gov
Cure8 trial brief
Clostridium Butyricum in Stenosing Crohn's Disease
Research and clinical trials
Microbiome
Biopsy
Colonoscopy
Stricture
Clinical Trial Phase 1
Adult patients
Clinicians
Why This Matters
People with stricturing Crohn’s disease currently lack effective medical treatments to prevent or reverse intestinal fibrosis; this trial explores a probiotic approach (and trehalose) aimed at stimulating autophagy, a cellular pathway linked to fibrosis and Crohn’s pathogenesis.
Who Should Pay Attention
Adults with stricturing (B2) Crohn’s disease, gastroenterologists and IBD clinicians, clinical researchers studying microbiome- or autophagy-targeted therapies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1, Phase 2
Enrollment40 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a registered interventional Phase 1/2 pilot trial testing the next-generation probiotic Clostridium butyricum (CBM 588), trehalose (an autophagy stimulator), their combination, or placebo in 40 adults with stricturing (Montreal B2) Crohn’s disease.
Participants will take the assigned oral intervention for two months before a clinically indicated colonoscopy; biopsies and blood samples collected during the procedure will be analyzed for autophagy markers (LC3b-II, p62), inflammatory and fibrotic gene expression, and oxidative-stress measures. The primary aims are to assess whether C.
butyricum is safe in this population and whether it can stimulate mucosal autophagy. Secondary analyses compare inflammation, fibrosis-related gene expression, and oxidative-stress markers across the four groups.
This description is drawn directly from the ClinicalTrials.gov record (trial NCT07263880) and summarizes the trial design and planned laboratory assessments. It does not report results or suggest clinical benefit.
Keep In Mind
This is an early-phase, small pilot study focused on mechanistic mucosal and blood biomarkers over a short (2-month) treatment window. The registry entry describes planned laboratory outcomes but does not provide efficacy or safety results. Enrollment and outcomes should be interpreted as preliminary until larger, controlled trials report clinical endpoints.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorSan Giovanni Addolorata Hospital
Trial IDNCT07263880
Study typeInterventional
Trial phasePhase 1, Phase 2
Enrollment40 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 4, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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