Effect of Bacillus Coagulans on Various Symptoms and Fecal Microbial Diversity in Adults With With Functional Constipation: a Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- constipation visual analogue scale
研究概览
简要总结
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.
详细描述
A previous study has indicated that Bacillus coagulans provided control of abdominal pain, less discomfort during defecation, and a more normalized defecation style, especially in adults with with functional constipation. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans various symptoms and fecal microbial diversity in adults with with functional constipation for 8 weeks; the safety of the compound are also evaluated. The Investigators examine constipation visual analogue scale, Bristol Stool Form Scale type 3 & 4 ratio, visual analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at baseline, as well as after 8 weeks of intervention. Eighty adults were administered either 400 mg of Bacillus coagulans or a placebo each day for 8 weeks.
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)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- function constipation by Romes criteria IV
排除标准
- •Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
- •Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
- •Uncontrolled hypertension (>160/100 mmHg)
- •Uncontrolled thyroid diseases.
- •History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
- •History of structural abnormalities of colon within 4 year
- •History of medication for probiotics and psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
- •Alcohol abuser
- •Allergic reaction to this test food
- •Those who participated in other drug clinical trials within 1 month from the screening date.
- •Severe gastrointestinal symptoms such as heartburn and indigestion
- •Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
- •Those who are judged to be unsuitable by the PI for other reasons
研究组 & 干预措施
Bacillus coagulans group
This group takes Bacillus coagulans for 12 weeks.
干预措施: Bacillus coagulans group (Dietary Supplement)
Control group
This group takes placebo for 12 weeks.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
constipation visual analogue scale
时间窗: 8 weeks
using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a worse outcome.
次要结局
- Bristol Stool Form Scale (BSFS) type 1 & 2 ratio (%)(8 weeks)
- visual analogue scale for irritable bowel syndrome(8 weeks)
- irritable bowel syndrome-symptom severity scale(8 weeks)
- irritable bowel syndrome-quality-of-life(8 weeks)
- fecal microbial diversity(8 weeks)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital