NCT06738433已完成1 期
Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial
AB Biotek2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年4月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Microbiota composition
研究概览
简要总结
In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who require hospitalization
- •Constipation defined as the Rome IV criteria for constipation
- •Patients with the ability to take the study product orally
排除标准
- •History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
- •History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
- •Patients last palliative care en stage of "end of life" or "terminal"
- •Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
- •Laxatives
- •Antibiotic treatment in the previous 2 weeks
- •Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation
结局指标
主要结局
Microbiota composition
时间窗: from baseline to day 14 of supplementation
Changes in microbiota composition through Shanon diversity test and statistical analyses (Continuous variables will be described as mean and standard deviation (SD) or as median and interquartile range; and categorical variables such as absolute frequencies and percentages).
次要结局
- Transit time(from baseline to day 14 of supplementation)
- Tolerance and gastro-intestinal comfort(from baseline to day 14 of supplementation)
- Brain Derived Neurotrophic Factor (BDNF)(from baseline to day 14 of supplementation)
研究者
研究点 (2)
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