Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease

NCT07799428 | Not Yet Recruiting DMC

• 1 other identifier: TNLS.2026.IBD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease and Ulcerative Colitis

Keywords

probiotics; spore; Bacillus; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 0, 7, 14 and 30

Secondary Outcomes (3)

• Changes in IBD disease activity

  Days 0, 7, 14 and 30

• Change in immune and inflammatory biomarkers

  Days 0, 14 and 30

• Gastrointestinal symptoms

  Days 0, 7,14 and 30

Other Outcomes (3)

• Change in the gut microbiome at day 30 compared to day 0

  Days 0 and 30

• Safety assessment: Clinically significant laboratory abnormalities

  Days 0, 14 and 30

• Change in endoscopic findings at Day 30 compared with baseline

  Days 0 and 30

Study Arms (3)

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.

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.

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.

Combination Product: LiveSpo® DIA30; Combination Product: LiveSpo® COLON

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 from Aquafina in an opaque plastic bottle

Placebo

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.

DIA30-COLON

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.

COLON; DIA30-COLON

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anabio R&D: lead
• Hanoi Medical University: collaborator

Study Sites (1)

Department of Gastroenterology

Hà Nội, Vietnam

Location

Related Publications (10)

• 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.

  PMID: 31435168 RESULT

• Elshaghabee 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.

  PMID: 28848511 RESULT

• Saez-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.

  PMID: 25793197 RESULT

• Le 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.

  PMID: 29854599 RESULT

• Marotto 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.

  PMID: 32998068 RESULT

• Guandalini 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.

  PMID: 39060735 RESULT

• Lamb 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.

  PMID: 29767705 RESULT

• Celiberto 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.

  PMID: 25996176 RESULT

• Gong 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.

  PMID: 26720180 RESULT

• Nimmons 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.

  PMID: 26855812 RESULT

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Anh N T, Assoc.Prof.

  Ha Noi Medical University

  STUDY CHAIR

• Khanh V Tran, Prof.

  Ha Noi Medical University

  PRINCIPAL INVESTIGATOR

• Anh TV Nguyen, Assoc.Prof.

  Spobio Research Center, Anabio R&D

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anh N Tran, Assoc.Prof.

CONTACT

(84)904831512; anhtn69@yahoo.com

Chi T Nguyen, MD, Specialist II

CONTACT

(84)912153567; chint0366@hmuh.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: LiveSpo DIA30, LiveSpo COLON, and RO water are indistinguishable in terms of smell. However, due to the opaque plastic container of the LiveSpo product suspension, the color and turbidity of the suspension are unrecognizable to investigators, except for the Principal Investigator (PI), analyzer, nurses, patient's parents, and patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, blind, controlled clinical trial.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: September 2, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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

Locations

VN (1)