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Completed

NCT Number: NCT05515887

Influence of Shenqu Xiaoshi Oral Liquid on Intestinal Microbiome of Children With Functional Dyspepsia

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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Key information

Conditions

Dyspepsia Child Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: SXOL

Primary outcomes

  1. Intestinal microbiome characteristics

    Time frame: 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.

  2. Intestinal microbiome metabolites

    Time frame: 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.

  3. Levels of hormones

    Time frame: Treatment for 2-week

    e.g., Gastrin and Motilin

  4. Levels of inflammatory cytokines

    Time frame: Treatment for 2-week

    e.g., TNF-α and IL-6

  5. Clinical symptoms evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Evaluation on the Influence of Shenqu Xiaoshi Oral Liquid for the Intestinal Microbiome of Children With Functional Dyspepsia

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 25, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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