Using Mycophenolate Mofetil for Gastrointestinal Issues in Children with Henoch-Schönlein Purpura
The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura
This study tests if a medication called Mycophenolate Mofetil can help children aged 3 to 18 with stubborn stomach problems caused by Henoch-Schönlein Purpura when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05951517 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Mycophenolate Mofetil (MMF) in treating children aged 3 to 18 years who have refractory gastrointestinal symptoms associated with Henoch-Schönlein Purpura (HSP). HSP is a common vasculitis in children that can lead to severe gastrointestinal complications. The study aims to assess the clinical features of these patients and the outcomes of MMF treatment after they have not responded to corticosteroids. Participants will be monitored for improvements in their gastrointestinal symptoms and overall health.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 18 years diagnosed with HSP who exhibit refractory gastrointestinal symptoms.
Not a fit: Patients with severe underlying diseases or those allergic to Mycophenolate Mofetil may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children suffering from severe gastrointestinal complications of HSP.
How similar studies have performed: Previous studies have shown that early glucocorticoid treatment can benefit HSP patients, but the use of MMF in this context is less established, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages range from 3 to 18 years old; 2. Patients who meet the diagnostic criteria for HSP and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination; 3. Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid 4. Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: 1. Patients who are allergic to MMF; 2. Patients with severe diseases: such as systemic malignancies, heart failure, liver and renal failure, Immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery; 3. Patients with other digestive system diseases; 4. Those who have previously used MMF clinical trials; 5. Other situations the researcher thought inappropriate to participate in the study.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Weiping Tan, PhD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Haiyan Wang, MD
- Email: wanghy78@mail.sysu.edu.cn
- Phone: +8613560489257
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.