Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05951517

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Henoch-Schönlein Purpura Gastrointestinal Injury Mycophenolate Mofetil	Drug: MMF	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura patients who were resistant to steroid were treated with MMF	Drug: MMF MMF treat refractory gastrointestinal Henoch-Schönlein purpura Other Names: steroid

Arm

Intervention/Treatment

Experimental: mycophenolate mofetil in refractory gastrointestinal Henoch-Schönlein purpura

patients who were resistant to steroid were treated with MMF

Drug: MMF

MMF treat refractory gastrointestinal Henoch-Schönlein purpura

Other Names:

steroid

Outcome Measures

Primary Outcome Measures

Incidence of Abdominal pain, hematemesis and bloody stools [6 months]
assessed by checklist

Secondary Outcome Measures

count of red blood cells in Stool [6 months]
Test for every week

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.