Probiotic for Alleviating Functional Constipation in Adults
Weizmannia Coagulans BC99 Improved Intestinal Motility and Chronic Constipation Through Regulating Gut Microbiota: a Randomized, Double-blind, Placebo-controlled Trial
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Henan
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Luoyang、Henan、中国、471000
- The School of Food and Bioengineering, Henan University of Science and Technolog
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
(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.
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Exclusion Criteria:
- 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. -
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:益生菌组
参与者每天收到一袋含有益生菌 BC99 和麦芽糖糊精(第 0 周至第 8 周)。
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在干预期间,参与者可以每天食用 BC99,并记录任何不良反应。
收集粪便和血清样本用于分析 16S rRNA 和血清炎症标志物。
评估补充前后肠道菌群和炎症因子的变化。
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安慰剂比较:安慰剂组
参与者每天收到一袋仅含有麦芽糖糊精的药袋,作为安慰剂(第 0 周至第 8 周)。
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在干预期间,参与者可以每天食用麦芽糖糊精,并记录任何不良反应。
收集粪便和血清样本用于分析 16S rRNA 和血清炎症标志物。
评估补充前后肠道菌群和炎症因子的变化。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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1. Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.
大体时间:8 weeks
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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.
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8 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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