An interventional study of RO and LiveSpo® DIA30 in Crohn Disease and Ulcerative Colitis, sponsored by Anabio R&D. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Anabio R&D · Not applicable, Interventional, and Treatment
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:
Intervention Description: A total of 150 eligible participants will be randomly assigned to three groups (n = per group).
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.
Inflammatory bowel disease (IBD) can affect individuals of all ages and is commonly associated with persistent diarrhea, abdominal pain, bloody stool, and, in some cases, extraintestinal manifestations such as arthritis, skin lesions, ocular involvement, and hepatobiliary disorders. If not well controlled, IBD may also increase the risk of colorectal cancer. The global incidence of IBD has been rising rapidly, including in Vietnam. Current therapies, including 5-aminosalicylic acid (5-ASA), corticosteroids, immunomodulators, biologic agents, and antibiotics when indicated. However, long-term disease management remains challenging.
Therapeutic strategies aimed at achieving sustained improvement in clinical symptoms and effective mucosal healing are increasingly recognized as important in IBD management. The gut microbiota plays a central role in intestinal inflammation, mucosal immune regulation, and epithelial barrier function. Therefore, probiotic intervention represents a potential supportive approach for patients with IBD. This approach may help improve clinical symptoms and support gut microbiota balance, while also potentially reducing barriers related to treatment costs and adverse effects associated with long-term or biological therapies. Among probiotic candidates, Bacillus species offer several advantages, including high survival under acidic and bile conditions, good room-temperature stability, suitability for oral formulation, and potential roles in mucosal immune modulation, digestive enzyme production, and inhibition of harmful bacteria.
The objective of this study is to evaluate the supportive therapeutic efficacy of multi-strain Bacillus spore probiotics in improving clinical symptoms in patients with IBD when used in combination with standard treatment, compared with standard treatment plus placebo, after 7, 14, and 30 days of using LiveSpo® COLON or the combined LiveSpo® DIA30 and LiveSpo® COLON regimen.
This will be a randomized, blinded, controlled clinical trial conducted over 12 months. Eligible patients aged 18-65 years with a confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, will be enrolled after providing written informed consent and meeting all eligibility criteria. A total of 150 participants will be randomly assigned to three groups (n = 50 per group): the Placebo group will receive oral RO water, the Colon group will receive LiveSpo® COLON, and the DIA30-COLON group will receive a combined regimen of LiveSpo® DIA30 and LiveSpo® COLON, with all groups continuing the hospital's standard IBD treatment regimen throughout the study period.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 150 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Anabio R&D is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the Placebo Group will receive the hospital's standard IBD treatment regimen combined with oral RO water as placebo, one 5 mL ampoule per dose, three times daily for 30 consecutive days. the standard IBD treatment regimen may include stepwise medical therapy with 5-aminosalicylic acid (5-ASA), corticosteroids during disease flares, immunomodulators, or biologic agents when clinically indicated. Supportive care, including antibiotics when infection is suspected or confirmed, fluid and electrolyte replacement, and nutritional support, will be applied consistently across groups. All standard treatments and concomitant medications used during the study period will be recorded. Laxatives and non-study probiotics will not be used during the intervention period.
Other: RO
Participants will receive the same standard IBD treatment regimen as the Placebo Group, combined with LiveSpo® COLON, one 5 mL ampoule per dose, three times daily for 30 consecutive days.
Combination Product: LiveSpo® COLON
Participants will receive the same standard IBD treatment regimen as the Placebo Group, combined with LiveSpo® DIA30, one 5 mL ampoule per dose, three times daily for the first 14 days, followed by LiveSpo® COLON, one 5 mL ampoule per dose, three times daily for the next 16 days.
Combination Product: LiveSpo® DIA30 · Combination Product: LiveSpo® COLON
Aquafina'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 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 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.
Time frame: Days 0, 7, 14 and 30
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.
Time frame: Days 0, 7, 14 and 30
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.
Time frame: Days 0, 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.
Time frame: Days 0, 7,14 and 30
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.
Time frame: Days 0 and 30
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.
Time frame: Days 0, 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.
Time frame: Days 0 and 30
Plan to share: Yes — Data or samples to be shared that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a study protocol, informed consent form (ICF), clinical study report (CSR). For more information or to submit a request, please contact anabio.r\&d2021@gmail.com
Started Sep 2026 (actual). Primary completion is estimated for Jul 2027, 10 months after the start.
Of 299 interventional studies with no phase under Crohn Disease, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 65. This study's planned 10 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Oct 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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