Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Anabio R&D
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in IBD-related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Placebo
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.
干预措施: RO (Other)
COLON
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.
干预措施: LiveSpo® COLON (Combination Product)
DIA30-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.
干预措施: LiveSpo® DIA30 (Combination Product)
DIA30-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.
干预措施: LiveSpo® COLON (Combination Product)
结局指标
主要结局
Change in IBD-related quality of life
时间窗: 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.
次要结局
- 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)