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.
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.
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.
Parallel
RO
Other interventionAquafina's distilled water and reverse osmosis (RO) water, produce by PepsiCo, have both obtained ISO 9001:2015 and ISO 22000:2018 certifications, which are internationally recognized standards for quality management and food safety management systems, respectively. The RO water ampoules are produced using a similar process as the LIVESPO DIA30/COLON but contain 5ml of high-quality distilled water from Aquafina in an opaque plastic bottle
LiveSpo® DIA30
Combination productLiveSpo® DIA30 is an oral liquid probiotic formulation registered with the Food Safety Department, Ministry of Health of Vietnam, under product registration number 6547/2019/ĐKSP. Each 5 mL ampoule contains Bacillus subtilis ANA48, Bacillus clausii ANA39 and Bacillus coagulans ANA40 at a total concentration of 5 × 10\^9 CFU/5 mL.
LiveSpo® COLON
Combination productLiveSpo® COLON is an oral liquid probiotic formulation registered with the Food Safety Department, Ministry of Health of Vietnam, under product registration number 10401/2019/ĐKSP. Each 5 mL ampoule contains Bacillus subtilis ANA3 and Bacillus clausii ANA39 at a total concentration of 3 × 10\^9 CFU/5 mL.
Change in IBD-related quality of life
Change in IBD-related quality of life is assessed using the IBDQ-32 score (points) on days 7, 14, and 30 compared with baseline. Day 30 is the primary assessment time point, while days 7 and 14 are used to monitor the trajectory of improvement during the intervention.
Changes in IBD disease activity
Changes in IBD disease activity are assessed using disease-specific scoring systems: the partial Mayo (pMayo) score for ulcerative colitis and the Crohn's Disease Activity Index (CDAI) for Crohn's disease. The proportions of patients achieving remission according to the respective scoring criteria are compared between groups from baseline to days 7, 14, and 30. Day 30 is the primary assessment time point, while days 7 and 14 are used to assess the progression of clinical response during the intervention.
Change in immune and inflammatory biomarkers
Changes from baseline in the concentrations of the pro-inflammatory cytokines IL-1β, IL-6, IL-8, IL-17, IL-23, and TNF-α; the anti-inflammatory cytokine IL-10; fecal IgA; and fecal calprotectin are assessed on days 14 and 30.
Gastrointestinal symptoms
Gastrointestinal symptoms are assessed at days 0, 7, 14, and 30 and include mean daily stool frequency (bowel movements/day); stool consistency according to the Bristol Stool Form Scale (types 1-7, with higher types indicating looser stools); presence of mucus in stool (yes/no); presence of blood in stool (yes/no); ... Changes from baseline and the proportions of participants with each symptom are compared between treatment groups.
Change in the gut microbiome at day 30 compared to day 0
Change in the relative taxonomic composition of the gut microbiome based on 16S rRNA gene sequencing of stool samples at Day 30 compared with Day 0.
Safety assessment: Clinically significant laboratory abnormalities
Number and percentage of participants with at least one new or worsened clinically significant laboratory abnormality from baseline, based on complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, estimated glomerular filtration rate (eGFR), and high-sensitivity C-reactive protein (hs-CRP), assessed at Days 14 and 30.
Change in endoscopic findings at Day 30 compared with baseline
Endoscopic findings will be assessed by comparison of gastrointestinal endoscopy or colonoscopy images obtained at baseline and Day 30. Changes in mucosal findings will be documented based on the endoscopic images. Previous endoscopic images obtained within 1 month before enrollment may be used as baseline data.
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Anabio R&D
Lead sponsor
Hanoi Medical University
Collaborator
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