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

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

Interventions

OTHER

RO

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

COMBINATION_PRODUCT

LiveSpo® DIA30

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.

COMBINATION_PRODUCT

LiveSpo® COLON

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.

Sponsors & Collaborators

• Hanoi Medical University

  collaborator OTHER

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Anh N T, Assoc.Prof. · Ha Noi Medical University

• Khanh V Tran, Prof. · Ha Noi Medical University

• Anh TV Nguyen, Assoc.Prof. · Spobio Research Center, Anabio R&D

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-26

Primary Completion

2027-07-15

Completion

2027-10-15

Countries

• Vietnam

Study Locations