NCT07799428 Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease
| NCT ID | NCT07799428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anabio R&D |
| Condition | Crohn Disease and Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-09-04 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-09-04 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Anh N T, Assoc.Prof.
STUDY CHAIR
Ha Noi Medical University
Frequently Asked Questions
Who can join the NCT07799428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Crohn Disease and Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07799428 currently recruiting?
Yes, NCT07799428 is actively recruiting participants. Contact the research team at anhtn69@yahoo.com for enrollment information.
Where is the NCT07799428 trial being conducted?
This trial is being conducted at Hà Nội, Vietnam.
Who is sponsoring the NCT07799428 clinical trial?
NCT07799428 is sponsored by Anabio R&D. The principal investigator is Anh N T, Assoc.Prof. at Ha Noi Medical University. The trial plans to enroll 150 participants.
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