Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease
Not applicable · Testing RO, LiveSpo® DIA30 and LiveSpo® COLON · 1 site · Anabio R&D
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing RO, LiveSpo® DIA30 (a combination product) and LiveSpo® COLON (a combination product) as a possible treatment. Condition(s) listed: Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2026-08-26 (planned).
- Main results expected around 2027-07-15 (estimate from the record).
- 1 study site listed in Vietnam.
Main thing being measured
- Change in IBD-related quality of life (Days 0, 7, 14 and 30)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease and Ulcerative Colitis |
| Lead sponsor | Anabio R&D |
| Collaborators | Hanoi Medical University |
| Enrollment | 150 (estimated) |
| Start date | 2026-08-26 |
| Primary completion (est.) | 2027-07-15 |
| First posted | 2026-09-02 |
| Last updated | 2026-09-02 |
| Official title | Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial |
| ClinicalTrials.gov ID | NCT07799428 |
Interventions
- RO (Other)
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… - LiveSpo® DIA30 (Combination Product)
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 (Combination Product)
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.
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology | Hà Nội | Vietnam |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.