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Examination of Gut Microbiome Shifts In Pediatric Henoch-Schonlein Purpura Patients Undergoing A Multi-drug Therapy Reveals The Importance of Fecal Gram-positive Bacteria

Study on the relationship between the composition and diversity of intestinal microflora and the changes of intestinal short chain fatty acids and intestinal barrier in children with Henoch Schonlein purpura

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033453
Enrollment
Unknown
Registered
2020-06-01
Start date
2014-05-01
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch-Schonlein Purpura

Interventions

HSP of treatment-naive (Group A):Antibiotics (Amoxicillin/Clavulanate or oral azithromycin )
HSP of treatment-naive (Group A):Glucocorticoid (Prednisone)
HSP of treatment-naive (Group A):Heparin
HSP of treatment-naive (Group A):Chinese patent drug (Safflower Yellow injection)
HSP of treatment-naive (Group A):Vitamin C
HSP of treatment-naive (Group A):Omeprazole
HSP of treatment-naive (Group A) :Ganciclovir

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: Between May 2014 and March 2015, 96 children who were between 4 to 16 years old were diagnosed with HSP in the Department of Pediatrics, the First Affiliated Hospital of Kunming Medical University. Among them, 33 subjects were recruited for the clinical study based on the following inclusion criteria (Figure S1): under 18 years of age; presence of two or more additional HSP-indicative symptoms (e.g., gastrointestinal, joint, and kidney symptoms) besides cutaneous lesion; no prior treatment for HSP; no administration of antibiotics within latest 2 months prior to entry. All the HSP subjects received the treatment that lasted between 5 to 21 days. For whole-metagenomic analyses, 10 individuals were randomly selected from the 33 HSP patients along with 9 healthy controls with comparable ages, body weight, and gender ratio. This study was approved by the Ethics Committee of Kunming Medical University. Signed informed consent was obtained from the guardians of all participants upon their enrollment. All procedures were conducted in compliance with the Declaration of Helsinki.

Exclusion criteria

Exclusion criteria: 1. There are less than 3 clinical symptoms of Henoch Schonlein purpura; 2. Outpatients; 3. Patients who are unable to take stool samples after admission or before discharge; 4. Patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Routine blood test;D-Dimer;Fibrinogen degradation products (FDP);Urine protein;Urinary Red Cells;C-reactive protein;Erythrocyte sedimentation rate;Immunoglobulin A;Fecal occult blood;Species analysis of fecal microorganism;

Countries

China

Contacts

Public ContactYongkun Huang

The First Affiliated Hospital of Kunming Medical University

hykkmyncnwd@163.com+86 13577097854

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026