Using fecal microbiota transplantation to treat gastrointestinal disorders in children
Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Functional Gastrointestinal Disorders in Children
NA · Tongji Hospital · NCT05753774
This study is testing whether a treatment called fecal microbiota transplantation can help children with gastrointestinal disorders feel better compared to standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 15 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT05753774 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of fecal microbiota transplantation (FMT) in children diagnosed with functional gastrointestinal disorders (FGIDs) based on the Rome IV criteria. The trial involves enrolling pediatric patients and dividing them into two groups: one receiving FMT and the other receiving conventional treatments. The researchers will monitor the outcomes and compare the effectiveness of both approaches over time, while also assessing any adverse reactions related to FMT. This approach aims to restore a healthy balance of gut microbiota in affected children.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with functional gastrointestinal disorders according to the Rome IV criteria.
Not a fit: Patients with organic gastrointestinal diseases or other chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for managing functional gastrointestinal disorders in children.
How similar studies have performed: There is limited existing research on the use of FMT for treating FGIDs in children, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wuhan
- Tongji Hospital — Wuhan, China (RECRUITING)
Study contacts
- Study coordinator: Biao Zou, MD
- Email: 464021552@qq.com
- Phone: 15871365900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Functional Gastrointestinal Disorders, FMT, Safety, efficacy