Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease

Brief summary (registry, in English)

Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis. Although current therapies can control inflammation, many patients still experience recurrent symptoms, treatment resistance, adverse effects, and impaired quality of life. Probiotics represent a promising adjunctive approach for IBD by restoring gut microbial balance, modulating mucosal immunity, supporting intestinal barrier function, and potentially improving symptoms while reducing unnecessary reliance on antibiotics or intensive treatments. In this study, researchers propose that oral supplementation with multi-strain Bacillus spore probiotics, when used in combination with standard IBD treatment, is safe and may provide additional clinical benefits by improving gastrointestinal symptoms, quality of life, and disease activity in patients with IBD. The objective of this study is to evaluate the safety and efficacy of Bacillus spore probiotics, including LiveSpo® COLON and LiveSpo® DIA30, in patients with inflammatory bowel disease. LiveSpo® COLON contains Bacillus subtilis ANA3 and Bacillus clausii ANA39 at a concentration of 3 × 10⁹ CFU/5 mL, while LiveSpo® DIA30 contains Bacillus subtilis ANA48, Bacillus clausii ANA39, and Bacillus coagulans ANA40 at a concentration of 5 × 10⁹ CFU/5 mL. Study Design: * Sample Size: 150 participants * Study Location: Department of Gastroenterology Intervention Description: A total of 150 eligible participants will be randomly assigned to three groups (n = per group). * The Placebo Group will receive standard IBD treatment combined with oral RO water, one ampoule per dose, three times daily for 30 consecutive days. * The COLON Group will receive standard IBD treatment combined with LiveSpo® COLON, one ampoule per dose, three times daily for 30 consecutive days * The DIA30-COLON Group will receive standard IBD treatment combined with LiveSpo® DIA30, one ampoule per dose, three times daily for the first 14 days, followed by LiveSpo® COLON, one ampoule per dose, three times daily for the next 16 days. All participants in the three groups will receive blinded, coded study products. Patients in all groups will follow the standard IBD treatment regimen of the hospital and use the assigned study products throughout the study period. Caregivers or clinical staff will monitor the health status of participants and record relevant information in their medical records. During the study, participants will be instructed not to use any additional probiotic products or solutions containing similar components. Study Duration: 12 months.

What you commit to

• Study type: Interventional
• Planned participants: 150
• From 4 Sept 2026 to the primary completion date, 15 Jul 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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