Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

Study Overview
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Brief Summary
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Henoch Schönlein purpura (HSP) is the most common type of vasculitis in children, with an incidence of  10/100,000, whereas >90% of the patients develop symptoms at <10 years of age. Although HSP is generally a self-limiting disease, it may also lead to severe complications, such as intestinal intussusception, infarction and perforation, as well as end-stage renal disease. The management of HSP includes symptomatic treatment and immunosuppressive therapy in certain patients. Previous retrospective studies have reported that most patients with gastrointestinal (GI) symptoms may benefit from early usage of glucocorticoid, whereas there are still a part of HSP patients with GI did not achieved remission after administering of steroid. Therefore, the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.

Detailed Description
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the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.

Official Title
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The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura

Conditions
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Henoch-Schönlein Purpura, Gastrointestinal Injury, Mycophenolate Mofetil

Intervention / Treatment
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* Drug: MMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages range from 3 to 18 years old; 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; Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: Patients who are allergic to MMF; 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; Patients with other digestive system diseases; Those who have previously used MMF clinical trials; Other situations the researcher thought inappropriate to participate in the study.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura<br>patients who were resistant to steroid were treated with MMF | Drug: MMF<br>* MMF treat refractory gastrointestinal Henoch-Schönlein purpura<br>* Other names: steroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Abdominal pain, hematemesis and bloody stools | assessed by checklist | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| count of red blood cells in Stool | Test for every week | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic purpura, complications,, renal involvement, gastrointestinal involvement, mycophenolate mofetil