Dupilumab treatment for children with refractory eosinophilic gastrointestinal disorders
Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children
Children's Hospital of Fudan University · NCT07257835
We will try subcutaneous dupilumab injections in children with refractory EGIDs to see if symptoms, tissue eosinophils, and tolerability improve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University (other) |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07257835 on ClinicalTrials.gov |
What this trial studies
This single-center observational protocol at Children's Hospital of Fudan University follows children with refractory eosinophilic gastrointestinal disorders who receive standard-dose subcutaneous dupilumab. Investigators will collect symptom measures, endoscopic and histologic findings including eosinophil counts, routine laboratory safety tests, and record adverse events during follow-up. Patients receive licensed dupilumab dosing in a real-world setting rather than an experimental dosing schedule. The goal is to describe clinical response and tolerability in pediatric patients who have not responded to conventional therapies.
Who should consider this trial
Good fit: Children with refractory eosinophilic gastrointestinal disorders, including those with refractory peptic ulcers and persistent disease despite standard therapies, are the intended candidates.
Not a fit: Children with active Helicobacter pylori infection, inflammatory bowel disease, parasitic infection, or cancer were excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, dupilumab could reduce gastrointestinal eosinophilia and symptoms and lessen reliance on long-term steroids or immunosuppressants in affected children.
How similar studies have performed: Dupilumab has shown significant efficacy in eosinophilic esophagitis and there are growing reports and small series suggesting benefit in eosinophilic gastritis and duodenitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of Refractory Peptic Ulcers * with Refractory Eosinophilic Gastrointestinal Disorders Exclusion Criteria: * with Active Helicobacter pylori infection at present. * with Inflammatory bowel disease * with Parasite infection * with Cancer
Where this trial is running
Shanghai
- 201102 — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Ying Huang
- Email: yhuang815@163.com
- Phone: 021-64931727
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: Eosinophilic Gastrointestinal Disorders