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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shenqu Xiaoshi Oral liquid | Experimental | Shenqu Xiaoshi Oral liquid will be taken orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenqu Xiaoshi Oral liquid | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Treatment for 2-week |
| Levels of hormones | e.g., Gastrin and Motilin | Treatment for 2-week |
| Levels of inflammatory cytokines | e.g., TNF-α and IL-6 | 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. | Treatment for 1-week and 2-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chundi Xu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 021 | China |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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