Crohn Disease and Ulcerative ColitisNCT07799428
Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease
A study testing RO, LiveSpo® DIA30 and LiveSpo® COLON in people with Crohn Disease and Ulcerative Colitis, run by Anabio R&D at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease and Ulcerative Colitis
- What is being tested?
- RO, LiveSpo® DIA30 and LiveSpo® COLON
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Sep 2026to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Department of Gastroenterology
Hà Nội
Chi TM Duong, Spec.II, (84) 962790850, duongmaichi88@gmail.com
About this study
Official title: Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial
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.
Read more
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.
Read the detailed description
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.
- Clinical assessments will be performed at baseline and on days 7, 14, and 30, while sub-clinical assessments, including blood parameters and cytokine levels in blood and stool samples, will be performed at baseline and on days 14 and 30. The main comparison will be based on changes from baseline to day 30. Exploratory analyses will assess changes in gut microbiome composition and endoscopic findings from baseline to day 30.
- The presence of Bacillus subtilis, Bacillus clausii, and Bacillus coagulans in stool samples will be assessed by real-time PCR at follow-up visits on days 7, 14, and 30 compared with day 0 to support assessment of product use compliance.
- Statistical analysis will be conducted using the chi-square test or Fisher's exact test for binary variables, and the t-test, Mann-Whitney test, or Wilcoxon test for continuous variables, depending on data distribution.
- Conditions
- Crohn Disease and Ulcerative Colitis
- Being tested
- RO, LiveSpo® DIA30, LiveSpo® COLON
- Keywords
- probiotics, spore, Bacillus, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROOther
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® DIA30Combination 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® COLONCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Other: RO |
| COLON | Experimental | 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. Receives: Combination Product: LiveSpo® COLON |
| DIA30-COLON | Experimental | 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. Receives: Combination Product: LiveSpo® DIA30; Combination Product: LiveSpo® COLON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 0, 7, 14 and 30
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Days 0, 7,14 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start4 Sep 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Crohn Disease and Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, blind, controlled clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anabio R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanoi Medical University
- Responsible party
- Sponsor
- Investigators
- Anh N T, Assoc.Prof., Study chair, Ha Noi Medical UniversityKhanh V Tran, Prof., Principal investigator, Ha Noi Medical UniversityAnh TV Nguyen, Assoc.Prof., Principal investigator, Spobio Research Center, Anabio R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799428
- Sponsor's protocol ID
- TNLS.2026.IBD
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yoo JH, Donowitz M. Intestinal enteroids/organoids: A novel platform for drug discovery in inflammatory bowel diseases. World J Gastroenterol. 2019 Aug 14;25(30):4125-4147. doi: 10.3748/wjg.v25.i30.4125.
PubMed 31435168Elshaghabee FMF, Rokana N, Gulhane RD, Sharma C, Panwar H. Bacillus As Potential Probiotics: Status, Concerns, and Future Perspectives. Front Microbiol. 2017 Aug 10;8:1490. doi: 10.3389/fmicb.2017.01490. eCollection 2017.
PubMed 28848511Saez-Lara MJ, Gomez-Llorente C, Plaza-Diaz J, Gil A. The role of probiotic lactic acid bacteria and bifidobacteria in the prevention and treatment of inflammatory bowel disease and other related diseases: a systematic review of randomized human clinical trials. Biomed Res Int. 2015;2015:505878. doi: 10.1155/2015/505878. Epub 2015 Feb 22.
PubMed 25793197Le B, Yang SH. Efficacy of Lactobacillus plantarum in prevention of inflammatory bowel disease. Toxicol Rep. 2018 Mar 2;5:314-317. doi: 10.1016/j.toxrep.2018.02.007. eCollection 2018.
PubMed 29854599Marotto D, Atzeni F, Ardizzone S, Monteleone G, Giorgi V, Sarzi-Puttini P. Extra-intestinal manifestations of inflammatory bowel diseases. Pharmacol Res. 2020 Nov;161:105206. doi: 10.1016/j.phrs.2020.105206. Epub 2020 Sep 28.
PubMed 32998068Guandalini S. Probiotics in the Treatment of Inflammatory Bowel Diseases. Adv Exp Med Biol. 2024;1449:135-142. doi: 10.1007/978-3-031-58572-2_8.
PubMed 39060735Lamb CA, O'Byrne S, Keir ME, Butcher EC. Gut-Selective Integrin-Targeted Therapies for Inflammatory Bowel Disease. J Crohns Colitis. 2018 Aug 22;12(suppl_2):S653-S668. doi: 10.1093/ecco-jcc/jjy060.
PubMed 29767705Celiberto LS, Bedani R, Rossi EA, Cavallini DC. Probiotics: The scientific evidence in the context of inflammatory bowel disease. Crit Rev Food Sci Nutr. 2017 Jun 13;57(9):1759-1768. doi: 10.1080/10408398.2014.941457.
PubMed 25996176Gong Y, Li H, Li Y. Effects of Bacillus subtilis on Epithelial Tight Junctions of Mice with Inflammatory Bowel Disease. J Interferon Cytokine Res. 2016 Feb;36(2):75-85. doi: 10.1089/jir.2015.0030. Epub 2015 Dec 31.
PubMed 26720180Nimmons D, Limdi JK. Elderly patients and inflammatory bowel disease. World J Gastrointest Pharmacol Ther. 2016 Feb 6;7(1):51-65. doi: 10.4292/wjgpt.v7.i1.51.
PubMed 26855812
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- TNLS.2026.IBD
- Conditions
- Crohn Disease and Ulcerative Colitis
- Keywords
- probiotics, spore, Bacillus, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anabio R&DIndustry (pharma, biotech, devices)
- Collaborators
- Hanoi Medical University
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Clinical assessments will be performed at baseline and on days 7, 14, and 30, while sub-clinical assessments, including blood parameters and cytokine levels in blood and stool samples, will be performed at baseline and on days 14 and 30. The main comparison will be based on changes from baseline to day 30. Exploratory analyses will assess changes in gut microbiome composition and endoscopic findings from baseline to day 30.
- The presence of Bacillus subtilis, Bacillus clausii, and Bacillus coagulans in stool samples will be assessed by real-time PCR at follow-up visits on days 7, 14, and 30 compared with day 0 to support assessment of product use compliance.
- Statistical analysis will be conducted using the chi-square test or Fisher's exact test for binary variables, and the t-test, Mann-Whitney test, or Wilcoxon test for continuous variables, depending on data distribution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This is a randomized, blind, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: ROParticipants 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. |
| COLON | Experimental | Combination Product: LiveSpo® COLONParticipants 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. |
| DIA30-COLON | Experimental | Combination Product: LiveSpo® DIA30, Combination Product: LiveSpo® COLONParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROAquafina'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 | Other | Placebo |
| LiveSpo® DIA30LiveSpo® 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. | Combination product | DIA30-COLON |
| LiveSpo® COLONLiveSpo® 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. | Combination product | COLON, DIA30-COLON |
Primary outcome
Change in IBD-related quality of life
Time frame: Days 0, 7, 14 and 30
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.
3 secondary outcomes
Changes in IBD disease activity
Time frame: Days 0, 7, 14 and 30
Change in immune and inflammatory biomarkers
Time frame: Days 0, 14 and 30
Gastrointestinal symptoms
Time frame: Days 0, 7,14 and 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Results publication: PubMed 31435168Yoo JH, Donowitz M. Intestinal enteroids/organoids: A novel platform for drug discovery in inflammatory bowel diseases. World J Gastroenterol. 2019 Aug 14;25(30):4125-4147. doi: 10.3748/wjg.v25.i30.4125.
- Results publication: PubMed 28848511Elshaghabee FMF, Rokana N, Gulhane RD, Sharma C, Panwar H. Bacillus As Potential Probiotics: Status, Concerns, and Future Perspectives. Front Microbiol. 2017 Aug 10;8:1490. doi: 10.3389/fmicb.2017.01490. eCollection 2017.
- Results publication: PubMed 25793197Saez-Lara MJ, Gomez-Llorente C, Plaza-Diaz J, Gil A. The role of probiotic lactic acid bacteria and bifidobacteria in the prevention and treatment of inflammatory bowel disease and other related diseases: a systematic review of randomized human clinical trials. Biomed Res Int. 2015;2015:505878. doi: 10.1155/2015/505878. Epub 2015 Feb 22.
- Results publication: PubMed 29854599Le B, Yang SH. Efficacy of Lactobacillus plantarum in prevention of inflammatory bowel disease. Toxicol Rep. 2018 Mar 2;5:314-317. doi: 10.1016/j.toxrep.2018.02.007. eCollection 2018.
- Results publication: PubMed 32998068Marotto D, Atzeni F, Ardizzone S, Monteleone G, Giorgi V, Sarzi-Puttini P. Extra-intestinal manifestations of inflammatory bowel diseases. Pharmacol Res. 2020 Nov;161:105206. doi: 10.1016/j.phrs.2020.105206. Epub 2020 Sep 28.
- Results publication: PubMed 39060735Guandalini S. Probiotics in the Treatment of Inflammatory Bowel Diseases. Adv Exp Med Biol. 2024;1449:135-142. doi: 10.1007/978-3-031-58572-2_8.
- Results publication: PubMed 29767705Lamb CA, O'Byrne S, Keir ME, Butcher EC. Gut-Selective Integrin-Targeted Therapies for Inflammatory Bowel Disease. J Crohns Colitis. 2018 Aug 22;12(suppl_2):S653-S668. doi: 10.1093/ecco-jcc/jjy060.
- Results publication: PubMed 25996176Celiberto LS, Bedani R, Rossi EA, Cavallini DC. Probiotics: The scientific evidence in the context of inflammatory bowel disease. Crit Rev Food Sci Nutr. 2017 Jun 13;57(9):1759-1768. doi: 10.1080/10408398.2014.941457.
- Results publication: PubMed 26720180Gong Y, Li H, Li Y. Effects of Bacillus subtilis on Epithelial Tight Junctions of Mice with Inflammatory Bowel Disease. J Interferon Cytokine Res. 2016 Feb;36(2):75-85. doi: 10.1089/jir.2015.0030. Epub 2015 Dec 31.
- Results publication: PubMed 26855812Nimmons D, Limdi JK. Elderly patients and inflammatory bowel disease. World J Gastrointest Pharmacol Ther. 2016 Feb 6;7(1):51-65. doi: 10.4292/wjgpt.v7.i1.51.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anh N T, Assoc.Prof. study chair
Ha Noi Medical University
Khanh V Tran, Prof. principal investigator
Ha Noi Medical University
Anh TV Nguyen, Assoc.Prof. principal investigator
Spobio Research Center, Anabio R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RO, LiveSpo® DIA30 and LiveSpo® COLON in people with Crohn Disease and Ulcerative Colitis, run by Anabio R&D at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anh N Tran, Assoc.Prof. ((84)904831512, anhtn69@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBD-related quality of life (time frame: Days 0, 7, 14 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07799428, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.