NCT06637397已完成不适用
Weizmannia Coagulans BC99 Relieves Constipation Symptoms by Regulating Inflammatory, Neurotransmitter, and Lipid Metabolic Pathways: A Randomized, Double-Blind, Placebo-Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
研究概览
简要总结
To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese adults who met the Rome III diagnostic criteria and were aged ≥20 years;
- •patients with chronic constipation (duration of more than 6 months, with less than 3 bowel movements per week and/or Bristol Scale Type 1 and 2);
- •patients in whom loose stools were rare without the use of laxatives;
- •The criteria for irritable bowel syndrome were insufficient;
- •patients that could complete the study according to the requirements of the trial protocol;
- •patients that had signed the informed consent form;
- •the study participants (including male subjects) had no fertility plans within 14 days before screening, and would voluntarily take effective contraceptive measures within 6 months after the end of the trial.
- •Only those who met all of the above conditions could be selected.
排除标准
- •(1) Those who took items with similar functions to the test subjects in the short term, which may have affected their judgment of the results; (2) those who regularly used drugs that affect bowel habits; (3) patients who changed their diet during the study (such as regularly using a high-fiber diet, according to the recommended food score (RFS)); (4) those who were allergic to probiotics or the ingredients used in this study, those with severe immunodeficiency, or those with serious psychological or psychiatric diseases; (5) women who were pregnant, breastfeeding, or planning to become pregnant; (6) those who suffered from diseases that may cause secondary constipation, such as diabetes, thyroid disease, Alzheimer's disease, severe metabolic diseases, malignant tumors, and severe lesions of important organs (cardiovascular, lung, liver, kidney, etc.); (7) those who had used antibiotics in the two weeks prior; (8) those who did not consume the test samples as required, or were not followed up on time, resulting in uncertainty of efficacy; (9) those who had participated in another clinical trial within one month before enrollment; (10) subjects who were judged by other researchers to be unsuitable for participation. Those who met any of the above conditions were not selected.
研究组 & 干预措施
Placebo Group
Placebo Comparator
Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).
干预措施: Placebo (Dietary Supplement)
Probiotic Group
Experimental
Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
时间窗: 8 weeks
Constipation symptoms are measured using Bristol Stool Form Scale (BSFS).
次要结局
未报告次要终点
研究者
研究点 (2)
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