A Phase 4 interventional study of Shenqu Xiaoshi Oral liquid in Dyspepsia and Child, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Ruijin Hospital · Phase 4, Interventional, and Treatment
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 50 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 360 are open to participants now.
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Exclusion Criteria:
Shenqu Xiaoshi Oral liquid will be taken orally.
Drug: Shenqu Xiaoshi Oral liquid
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.
Also known as: SXOL
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
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital