NCT05982743已完成不适用
A Pilot Study of Using Fermented Milk Containing Lactobacillus Casei Strain Shirota (LcS) in Some Constipated Adults Having High Prevalence of Hard Stools in Vietnam
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements
研究概览
简要总结
The objective of this study is to provide evidence supporting the efficacy of fermented milk containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A randomized, controlled trial has been designed on constipated adults with a high prevalence of hard stools in Vietnam.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male, aged between 18 to 60 years.
- •Aware of producing hard or lumpy stools (BS score of 1 or 2) frequently.
- •Produce hard or lumpy stools (BS score of 1 or 2) ≥ 25% of bowel movements during 2 weeks of screening period.
- •Voluntarily provide written informed consent to participate in the study.
排除标准
- •Subjects whose constipation symptoms are caused by primary organic disease of the colon or pelvic floora or which, in the Investigator's opinion, is caused by medication (e.g. morphine, codeine).
- •Subjects with metabolic disorders, neurological disorders or any significant diseases or concomitant condition (e.g. abdominal/gastrointestinal surgery) that, in the investigator's opinion, would interfere with participation in the study.
- •Subjects with any known allergic reactions to any ingredients of milk.
- •Pregnant or nursing (breast-feeding) women.
- •Subjects who are unable to refrain from or anticipate the use of any medication (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and herbal supplements), except for paracetamol, oral contraceptives, or hormonal replacement therapy from 2-week before the initiation of screening of subject BS score to the end of the study.
- •Subjects who are unable to refrain from or anticipate the use of any probiotics, prebiotics or yogurts from 2-week before the initiation of screening of subject BS score to the end of the study.
- •Participation in another study with Investigational product within 2 months prior to this study.
- •Drug or alcohol abuse.
结局指标
主要结局
Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements
时间窗: During four weeks from the date of the site visit to submit a baseline stool sample.
Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include "Groups (Yakult/non-treatment)", "Weeks (first/second two weeks of the intervention period)", "baseline (median BS score during baseline)" and "Gender (women/men)" as the independent variables. "Groups x Weeks" interaction will not be included because it was absent in the past RCT studies giving Yakult.
次要结局
- Stool frequency with hard or lumpy one (BS score of 1 or 2)(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool frequency with ideal stool (BS score of 4)(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool frequency, as measured by a daily stool diary(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No)(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No)(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No)(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No)(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Chinese Constipation Questionnaire score(During four weeks from the date of the site visit to submit a baseline stool sample.)
- Stool microbiota (increase in the abundance of bifidobacteria)(During four weeks from the date of the site visit to submit a baseline stool sample.)
研究者
研究点 (2)
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