Weizmannia Coagulans BC99 Improved Intestinal Motility and Chronic Constipation Through Regulating Gut Microbiota: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. 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 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Chinese adults aged 18-70 years who meet the Rome IV diagnostic criteria for chronic constipation (duration of at least 6 months, with less than three passing stools per week and/or Bristol Stool Scale types 1 and 2); (2) The patient rarely experiences diarrhea without using laxatives; (3) The criteria for irritable bowel syndrome were insufffcient ; (4) patients that could complete the study according to the requirements of the trial protocol; (5) participants (including male subjects) who have no family planning within 14 days prior to screening and voluntarily take effective contraceptive measures within 6 months after the end of the trial; (6) Patients capable of understanding the clinical study and willing to comply with the study requirements and procedures; (7) Subjects who have signed the informed consent form. Only those who meet all the above conditions can be selected for the study.
排除标准
- •Use of probiotics, prebiotics, or antibiotics within two weeks prior to enrollment and throughout the intervention period;
- •Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
- •Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea;
- •Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, ulcerative colitis, malignant tumor of the colon;
- •Medical history of cardiovascular, liver, or renal diseases; alcoholics;
- •Hypersensitivity to probiotics or the ingredients used in this study;
- •Pregnancy or breastfeeding;
- •Participation in another clinical trial in the 3 months before enrollment. -
研究组 & 干预措施
Probiotic Group
Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).
干预措施: Probiotic (Dietary Supplement)
Placebo Group
Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
1. Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
时间窗: 8 weeks
Constipation symptoms are measured using Bristol Stool Form Scale, which classifies stool into seven types (1-2 indicate constipation, 3-4 normal, and 5-7 diarrhea) for self-assessment or clinical evaluation of bowel function.
次要结局
未报告次要终点