NCT05980988已完成不适用
Efficacy and Safety of Probiotic BLa80 in Modulating Bowel Habits in Subjects With Chronic Constipation
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
- 46
- 试验地点
- 2
- 主要终点
- changes in fecal state
研究概览
简要总结
To evaluate the effectiveness and safety of the use of probiotics as food supplements in regulating the intestinal habit of subjects with chronic constipation, in comparison with placebo.
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
- Single (Participant)
盲法说明
Double（Participant, Investigator)
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
- •Patients with chronic constipation (duration more than 3 months with less than three bowel movements per week and/or Bristol Scale 1 and 2).
排除标准
- •Diabetic patients.
- •Pregnant patients.
- •Breastfeeding patients.
- •Patients requiring antibiotic treatment.
- •Patients requiring treatment with tricyclic antidepressants, antiepileptics, antihistamines, antiparkinsonians, antipsychotics, antispasmodics, verapamil, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium), antidiarrheals and nonsteroidal anti-inflammatory drugs.
- •Patients who change the type of diet during the study.
- •Patients with allergy or intolerance to any of the ingredients in the formulation of the product under study.
- •Subjects with a history of pharmacological, alcoholic, or other substance abuse, or other factors that limit their ability to cooperate during the study.
- •Excessive alcohol consumption (>3 glasses of wine or beer/day).
- •Subjects whose condition does not make them eligible for the study, according to the researcher.
研究组 & 干预措施
placebo
Placebo Comparator
Maltodextrin, one capsule/day, before meals； Storage: Store in a cool, dry place without exposure to the sun.
干预措施: Placebo (Dietary Supplement)
Probiotic group
Experimental
2B CFU/capsule/day BLa80, before meals； Storage: Store in a cool, dry place without sun exposure.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
changes in fecal state
时间窗: 84 days
use Bristol Scale to record the type of fecal state
次要结局
未报告次要终点
研究者
研究点 (2)
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