Bacillus probiotic spores to help treat Crohn's disease and ulcerative colitis
Official title: Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial
Run by Anabio R&D · NCT07799428 · Data updated 2026-11-12
This study tests whether adding multi-strain Bacillus spore probiotics to standard IBD treatment helps people with Crohn's disease or ulcerative colitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Anabio R&D Industry-sponsored |
| Drugs / interventions | vedolizumab |
| Locations | 1 site (Hà Nội) |
| Status | Recruiting |
| Started | September 4, 2026 |
| Main results expected | July 15, 2027 |
| Study ends | October 15, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07799428 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with a confirmed diagnosis of ulcerative colitis or Crohn's disease receiving care at Hanoi Medical University Hospital and who have at least 14 days of treatment or follow-up planned.
✕Probably not a fit
Patients with significant organ dysfunction, immune disorders, or inability to adhere to the investigational regimen may not benefit and could be at higher risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the safety and potential added benefit of oral Bacillus spore probiotics (LiveSpo products) alongside usual IBD therapy. Eligible adults with Crohn's disease or ulcerative colitis at Hanoi Medical University Hospital will receive the probiotic combination in addition to their standard care, with adherence monitored over at least 14 days. Outcomes center on gastrointestinal symptoms, quality of life, and disease activity, while safety and tolerability are closely tracked. The trial leverages the probiotics’ potential to support mucosal barrier function and modulate gut immunity as an adjunct to existing treatments.
Why it matters
Potential benefit: If successful, participants may experience improved symptoms and quality of life beyond standard therapy.
How similar studies have gone: Probiotic approaches have shown mixed but encouraging signals in IBD; this study applies a Bacillus spore formulation to a Vietnamese patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 65 years. * Confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, according to the routine diagnostic procedures of Hanoi Medical University Hospital. * Receiving examination and treatment at Hanoi Medical University Hospital (including both inpatients and outpatients), with a minimum treatment or follow-up duration of 14 days * Willing and able to provide written informed consent. Exclusion Criteria: * Refusal to participate in the study. * Withdrawal from the study before completing 14 days of treatment. * Inability to comply with study procedures or inability to ensure adherence to the investigational product, as assessed by the investigator. * Moderate to severe hepatic or renal dysfunction, or other moderate to severe chronic cardiovascular, pulmonary, hepatic, or renal diseases that may affect general health status or require specialist treatment. * Presence of immune-related diseases. * Current use, or use within 4 weeks prior to screening, of biologic immunosuppressive therapies (for example, anti-TNF-α agents or vedolizumab).
Where it's running
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Department of Gastroenterology
Hà Nội, Vietnam Recruiting
Study contacts
- Principal investigator: Khanh V Tran, Prof. — Ha Noi Medical University
- Study coordinator: Anh N Tran, Assoc.Prof.
- Email: anhtn69@yahoo.com
- Phone: (84)904831512
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.