NCT06444139已完成不适用
A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Probiotics on Gastrointestinal Function in Adults With Occasional Constipation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Transit time
研究概览
简要总结
The goal of this clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. The main question it aim to answer is if intake of probiotics will decrease the transit time. Participants will randomized to either consume probiotics or a placebo product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females aged 18 - 65 years
- •With occasional constipation
- •Agrees to maintain current lifestyle habits
- •Provided voluntary, written, informed consent to participate in the study
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, or intolerance to study products or clinical assessment materials
- •Chronic constipation
- •Current or history of significant diseases or abnormalities of the gastrointestinal tract (examples (include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
- •Unstable metabolic disease or chronic diseases
- •Unstable hypertension.
- •Type I or Type II diabetes, cancer
- •Significant cardiovascular event in the past 6 months. History of or current diagnosis with kidney and/or liver diseases
- •Self-reported confirmation of current or pre-existing thyroid condition.
- •Individuals with an autoimmune disease or are immune compromised
- •Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis, blood/bleeding disorders
- •Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
结局指标
主要结局
Transit time
时间窗: Baseline to day 56
Difference in change in gut transit time as assessed by blue-dye method
次要结局
- Bowel movements(Baseline to day 28 and day 56)
- Stool consistency(Baseline to day 28 and day 56)
- Bloating and flatulence(Baseline to day 28 and day 56)
- Quality of life(Baseline to day 28 and day 56)
- Digestive symptoms(Baseline to day 28 and 56)
研究者
研究点 (1)
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