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Search / Trial NCT05753774

Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders

Launched by BIAO ZOU · Feb 22, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Functional Gastrointestinal Disorders; Fmt; Safety; Efficacy Efficacy

ClinConnect Summary

This clinical trial is studying a treatment called Fecal Microbiota Transplantation (FMT) for children with Functional Gastrointestinal Disorders (FGIDs). FGIDs can cause symptoms like stomach pain and discomfort without any clear physical causes. The researchers want to see if FMT, which involves transferring healthy bacteria from a donor's stool to help restore a balanced gut environment, is safe and effective for pediatric patients.

To participate, children aged 1 to 15 years old (365 to 5478 days old) who have been diagnosed with FGIDs according to specific guidelines (the ROME IV criteria) may be eligible. However, children with other serious gastrointestinal diseases or chronic health issues, as well as those who are not growing well, will not be included. If enrolled, participants will receive the FMT treatment and will be monitored to understand how well it works and if there are any side effects. This trial is currently looking for volunteers, so families interested in this treatment option can consider joining.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • The diagnosis and classification of patients with FGIDs were in accordance with the ROME IV criteria for children
  • Exclusion Criteria:
  • organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.)
  • other chronic disease
  • growth failure

About Biao Zou

Biao Zou is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodologies and ethical standards, Biao Zou oversees the design, implementation, and management of clinical trials across various therapeutic areas. The organization collaborates with healthcare professionals, research institutions, and regulatory bodies to ensure the highest quality of data and patient safety. By fostering a culture of transparency and collaboration, Biao Zou aims to contribute significantly to the development of groundbreaking treatments that address unmet medical needs.

Locations

Wuhan, , China

Patients applied

0 patients applied

Trial Officials

Zhihua Huang

Study Director

Tongji Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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