A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Gut Health and Immunomodulatory Effects of Bacillus Subtilis-based Product in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- • Change in fecal calprotectin levels from baseline to the end of the study.
研究概览
简要总结
The goal of this clinical trial is to Assess Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults The main question[s] it aims to answer are to assess the effects of Bacillus Subtilis on gut health in healthy adults by measuring changes in fecal calprotectin levels as a marker of intestinal inflammation, in comparison between the intervention and placebo group.
To assess the immunomodulatory effects of Bacillus-Subtilis by measuring changes in inflammatory and immune response markers, in comparison between the intervention and placebo group To confirm the safety and tolerability of the study product Bacillus Subtilis in the healthy study population during the intended use, with safety assessments conducted across both the intervention and placebo groups.
The primary and secondary outcomes are:
Primary Efficacy Outcome:
- Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups.
- Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups.
Secondary Efficacy Outcome:
• Improvement in the patient related overall relief, assessed using Gut Health Status Questionnaire (GHSQ) and Immune status questionnaire (ISQ) score with comparative analysis between the two groups.
Participants will be asked to take the probiotics twice daily morning and evening after meals and record it in the subject diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged between 18 and 50 years.
- •Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- •In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
- •Willing to provide fecal samples as per the study requirements.
- •Willing to participate voluntarily and provide written informed consent.
排除标准
- •Women who are pregnant or lactating.
- •Subjects who are taking Antibiotic treatment.
- •Subjects suffering from Gastrointestinal disease.
- •Subjects suffering from Diabetes.
- •Subjects suffering from Chronic/iatrogenic Immunodeficiency.
- •Subjects suffering from Abnormal blood pressure.
- •Subjects who are allergic to ingredients of the study Product.
- •Subjects who are Smoker or alcoholic.
- •Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
- •Women who are pregnant, breastfeeding, or planning to become pregnant.
- •Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
- •Subjects with medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV) or taking medications that may impact the immune system, such as antibiotics, antimicrobials, or probiotic sachets.
- •Any surgical treatment within the previous three months or planned during the study.
- •Any subject, in the principal investigator's opinion, not considered suitable for enrolment.
研究组 & 干预措施
Probiotics
Bacillus subtilis
干预措施: Probiotics (Bacillus Subtilis) (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
• Change in fecal calprotectin levels from baseline to the end of the study.
时间窗: Baseline to Week 8 (or end of study)
Fecal calprotectin concentration (µg/g) will be measured at baseline and at the end of the study. The change from baseline will be analyzed.
次要结局
- Change in Gut Health Status Questionnaire (GHSQ) Total Score from Baseline to End of Study(Baseline to Week 8 (End of Study))
- Change in Serum Immunoglobulin A (IgA) Concentration from Baseline to End of Study(Baseline to Week 8 (or end of study))
- Change in Serum Immunoglobulin G (IgG) Concentration from Baseline to End of Study(Baseline to Week 8 (or end of study))
- Change in Serum Immunoglobulin M (IgM) Concentration from Baseline to End of Study(Baseline to Week 8 (or end of study))
- Change in Immune Status Questionnaire (ISQ) Total Score from Baseline to End of Study(Baseline to Week 8 (End of Study))