Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation: a Prospective Randomized Controlled Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the number of fully autonomous bowel movements per week at the end of treatment
研究概览
简要总结
In this study, we will evaluate the efficacy of prebiotics combined with quadruple probiotics in the treatment of functional constipation through an open RCT study. The experimental group received lifestyle guidance and combined intervention of prebiotics and quadruple probiotics at the same time. The patients took the combination of prebiotics and probiotics twice a day during the treatment period. The control group received only lifestyle instruction. At the same time, to evaluate the safety of probiotics combined with quadruple probiotics in the treatment of functional constipation, and provide a new treatment plan for clinical treatment of functional constipation.
详细描述
The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation.
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
- 否
入选标准
- •Age: between 18 and 60 years old
- •Functional constipation was diagnosed using Rome IV criteria.
- •No other relevant medications that may affect the gut microbiota before the start of the experiment
- •Ability to participate
- •Consent to participate in the study
排除标准
- •Organic constipation (such as intestinal obstruction, bowel cancer, etc.)
- •Outlet obstructive constipation
- •Previous abdominal, rectal, or perianal surgery except cholecystectomy, appendectomy, tubal ligation, and cesarean section
- •Patients with constipation-oriented irritable bowel syndrome (IBS-C) or functional abdominal pain syndrome who meet Rome IV criteria
- •a serious mental illness or any medical condition related to it
- •Diseases of the small or large intestine, such as ulcerative colitis and Crohn's disease
- •There are serious important organs such as respiratory, heart, liver, kidney and other functional insufficiency
- •Use probiotics, prebiotics and/or Biostime within 1 month
结局指标
主要结局
Change in the number of fully autonomous bowel movements per week at the end of treatment
时间窗: A month after treatment
Change in the number of fully autonomous bowel movements per week at the end of treatment
次要结局
未报告次要终点