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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The dosage was determined by age: 3-4 years old, 5 ml/dose; 5-14 years old 10 ml/dose. Taken half an hour after meals, three times a day.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Intestinal microbiome characteristics
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.
Time frame: Treatment for 2-week
Intestinal microbiome metabolites
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.
Time frame: Treatment for 2-week
Levels of hormones
e.g., Gastrin and Motilin
Time frame: Treatment for 2-week
Levels of inflammatory cytokines
e.g., TNF-α and IL-6
Time frame: Treatment for 2-week
Clinical symptoms evaluation
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.
Time frame: Treatment for 1-week and 2-week
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