Impact of Heyndrickxia (Bacillus) Coagulans Probiotic on Gastrointestinal Function in Healthy Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Stool frequency
研究概览
简要总结
A single centre, double-blind, placebo-controlled study to evaluate the effect of the consumption of Bacillus coagulans at a daily dose of 1 x 10⁹ CFU on bowel habits, intestinal microbiota and gastrointestinal symptoms in healthy adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1- Adults male or female aged 18-65 years old. 2- Generally healthy but with irregular bowel movements, including <4 stools/week or periodic (over 2/week) loose stools 2- Agreed not to take other probiotics or prebiotics products during the study period, unless specified by the investigator.
- •3- Subjects enrolled in the study voluntarily and signed the Consent Form.
排除标准
- •Subjects aged <18 or > 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
- •Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
- •Subjects with constipation symptoms caused by surgical operation within the past 30 days; subjects with acute GI track diseases in the past 30 days; subjects with constipation symptoms due to severe organ lesion (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.)
- •Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
- •Subjects administered relevant products recently, which would affect the outcome of the study.
- •Subjects who took probiotics or prebiotics products (including yogurt, beverages or foods containing probiotics) within the past month, which may affect the results of the study.
- •Subjects who suffered from gastrointestinal disease within the past month.
- •Subjects who had taken antibiotics in the past month.
- •Subjects who had not taken the test product as prescribed or took other supplements or drugs.
- •Subjects with incomplete data or incomplete information, so that the efficacy could not be estimated.
结局指标
主要结局
Stool frequency
时间窗: 6 weeks period, from enrollment to the end of the study.
Changes in stool frequency, defined as the number of stools per day. Participants will record their daily stool frequency in a Health Daily Diary. Comparisons will be made between the intervention group and the control group and between timepoints, specifically at each week during the 2-week run-in period and each week from Week 1 to Week 4.
Stool consistency.
时间窗: 6 weeks period, from enrollment to the end of the study.
Changes in stool consistency will be assessed using the standard Bristol Stool Scale (BSS). Participants will record their daily stool consistency in a Health Daily Diary. Comparisons will be made between the intervention group and the control group and between timepoints. Specifically, at each week during the 2-week run-in period and each week from Week 1 to Week 4.
Improvement of constipation rate
时间窗: 6 weeks period, from enrollment to the end of the study.
Constipation is defined as present if a participant has \<4 stools/week and absent if 4 stools/week or more were noted. Analysis will be conducted using data on stool frequency collected by the participants in the Health Daily Diary. Comparisons will be made between groups and between timepoints. Specifically at each week during the 2-week run-in period and each week from Week 1 to Week 4.
Improvement in the defection effort
时间窗: 6 weeks period, from enrollment to the end of the study.
Data on symptoms during defection will be collected from the Health Daily Diary and scored as: 0=normal stool habit, 1=defection with mild discomfort, 2= defection with discomfort and difficulty, or 3=defection with frequent abdominal pain or burning. Comparisons will be made between the intervention group and control group and between timepoints. Specifically, at each week during the 2-week run-in period and each week from Week 1 to Week 4.
Changes in intestinal microbiota
时间窗: 4 weeks period, assessment at Day 0, Day 14 and Day28
Assessment of changes in the diversity of the fecal microbiota and relative abundance after intervention. Comparisons will be made between groups and between timepoints. Specifically at specifically at baseline (Day 0), Day 14, and Week 28 (end of the study).
Improvement in digestive symptoms scores
时间窗: 6 weeks; assessment at Day 0, Day 14 and Day 28
Assessed by the Gastrointestinal Symptom Rates Scale (GSRS).The GSRS has 15 items rated on a seven-point Likert scale from no discomfort to very severe discomfort. These items are grouped into five domains: abdominal pain, reflux, diarrhea, indigestion, and constipation. Scores are the mean of items within each domain, with higher scores indicating more severe symptoms. The overall GSRS score is the average of the five domain scores. Comparisons will be made between the intervention and control groups and at days 0, 14, and 28.
Improvement in upper GI symptoms
时间窗: 6 weeks; assessment at Day 0, Day 14 and Day 28
The Severity Of Dyspepsia Assessment (SODA) tool evaluates four symptoms: dyspepsia, heartburn, reflux, and nausea. Each symptom is rated by frequency: 1 (none per week), 2 (once per week), 3 (1-2 times per week), 4 (3-4 times per week), and 5 (daily or more). A decrease in the score over time indicates an improvement in symptoms. Comparisons will be made between the intervention and control groups and at days 0, 14, and 28.
次要结局
- Safety assessment- Blood pressure (vitals)(Day 0, Day 14 and Day 28)
- Assessment of the impact of the intervention on the quality of life(6 weeks; assessment at Day 0, Day 14 and Day 28.)
- Safety assessment-Safety as measured by adverse events(from Day 0 to Day 28)
- Safety assessment -liver function- Aspartate Aminotransferase (AST)(Day 0 and Day 28)
- Safety assessment- Liver profile-alanine aminotransferase (ALT)(Day 0 and Day 28)
- Safety assessment- Liver profile- Bilirubin(Day 0 and Day 28)
- Safety assessment- Heart rate (vitals)(Day 0, Day 14 and Day 28)
- Safety assessment-ECG findings(Day 0)
- Safety assessment-urine analysis(Day 0 and Day 28)
- Safety assessment-stool analysis(Day 0 and Day 28)
- Safety assessment- Chest X-ray findings(Day 0)
- Safety assessment- Kidney profile-Urea(Day 0 and Day 28)
- Safety assessment- Kidney profile-Creatinine(Day 0 and Day 28)
- Safety assessment- Lipid Profile(Day 0 and Day 28)
- Safety assessment- Blood Glucose levels(Day 0 and Day 28)