Evaluation on the Influence of Shenqu Xiaoshi Oral Liquid for the Intestinal Microbiome of Children With Functional Dyspepsia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Levels of hormones
研究概览
简要总结
It has been confirmed that treatment with Shenqu Xiaoshi Oral liquid (SXOL) effectively improves dyspeptic symptoms and is well tolerated. It is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with functional dyspepsia (FD). This study aims to evaluate the possible regulatory effect of SXOL on intestinal microbiome in children with FD, further exploring its related mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients aged 3-14 years old;
- •Meeting ≥1 condition(s): (1)Postprandial fullness;(2)early satiation;(3)Epigastric pain or burning not associated with defecation;
- •Having symptoms at least 2 months and at least 4 days per month before diagnosis;
- •During the 2-wk lead-in period, no relevant drugs for the treatment of dyspepsia and anorexia were used, good eating habits have been established, and the FD symptoms still existed (symptom score≥3).
- •Informed consent was obtained from the parents/guardians of the participant. If the child was more than 8 years old, additional informed consent would be required from the participant.
排除标准
- •Anorexia and dyspepsia caused by certain drugs and confirmed organic diseases such as erosive gastritis, peptic ulcer, etc;
- •Severe malnutrition;
- •Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and endocrine systems;
- •Mental disorders, intellectual disabilities, and/or communication impairments;
- •Lactose intolerant or allergic to the ingredients of Shenqu Xiaoshi Oral Liquid or Traditional Chinese medicine;
- •Probiotics or antibiotics within 4-wk;
- •Participated in a clinical trial within the past 12-wk;
- •Individuals deemed unsuitable for this clinical trial.
研究组 & 干预措施
Shenqu Xiaoshi Oral liquid
Shenqu Xiaoshi Oral liquid will be taken orally.
干预措施: Shenqu Xiaoshi Oral liquid (Drug)
结局指标
主要结局
Levels of hormones
时间窗: Treatment for 2-week
e.g., Gastrin and Motilin
Clinical symptoms evaluation
时间窗: Treatment for 1-week and 2-week
Measured by a scale filling by subjects or their parents. The scale contains clinical symptoms of functional dyspepsia, such as postprandial fullness and early satiation. Scores range from 0 to 3 and higher scores represent more severe or more frequent.
Intestinal microbiome characteristics
时间窗: Treatment for 2-week
All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics (e.g., the α and β diversity, the abundance of changed species) and composition of intestinal microbiome.
Intestinal microbiome metabolites
时间窗: Treatment for 2-week
Microbiome metabolites (e.g., short-chain fatty acid and bile acid) will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MC) non-targeted metabolomics.
Levels of inflammatory cytokines
时间窗: Treatment for 2-week
e.g., TNF-α and IL-6
次要结局
未报告次要终点