Clinical trial NCT05951517: Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura
Official title: The Clinical Study of Mycophenolate Mofetil in Pediatric Refractory Gastrointestinal Henoch-Schonlein Purpura
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Henoch-Schönlein Purpura
Gastrointestinal Injury
Mycophenolate Mofetil
Keywords: Allergic purpura
complications,
renal involvement
gastrointestinal involvement
mycophenolate mofetil
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Abdominal pain, hematemesis and bloody stools
timeFrame: 6 months
Secondary outcomes:
measure: count of red blood cells in Stool
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Weiping Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References: