Child, Dyspepsia
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatients aged 3-14 years old; 2. Meeting ≥1 condition(s): (1)Postprandial fullness;(2)early satiation;(3)Epigastric pain or burning not associated with defecation; 3. Having symptoms at least 2 months and at least 4 days per month before diagnosis; 4. 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). 5. 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.
Exclusion criteria
1. Anorexia and dyspepsia caused by certain drugs and confirmed organic diseases such as erosive gastritis, peptic ulcer, etc; 2. Severe malnutrition; 3. Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and endocrine systems; 4. Mental disorders, intellectual disabilities, and/or communication impairments; 5. Lactose intolerant or allergic to the ingredients of Shenqu Xiaoshi Oral Liquid or Traditional Chinese medicine; 6. Probiotics or antibiotics within 4-wk; 7. Participated in a clinical trial within the past 12-wk; 8. Individuals deemed unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of inflammatory cytokines | Treatment for 2-week | e.g., TNF-α and IL-6 |
| Intestinal microbiome characteristics | 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 | 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 hormones | Treatment for 2-week | e.g., Gastrin and Motilin |
| Clinical symptoms evaluation | 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. |
Countries
China
Outcome results
None listed