Effect of Lactobacillus Plantarum IS-10506 supplementation on systemic and humoral mucosal immune responses in children with HIV infection with antiretroviral therapy
Not Applicable
Completed
- Conditions
- Children with HIV infection with antiretroviral therapyHIV infected childrenantiretroviralL.plantarum IS�CD4+ T cell levelCD4+/CD8+ T cell ratiofecal sIgA
- Registration Number
- TCTR20180525003
- Lead Sponsor
- Faculty of Medicine, Universitas Airlangga
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Children 5-18 years old
HIV infected (based on WHO criteria), with an absolute CD4+ T cell count ≥ 350 cells/mm3
Receiving antiretroviral therapy, for a minimum 6 months prior to inclusion
Exclusion Criteria
Infected HIV children that withdrew antiretroviral therapy
Receiving probiotic supplementation 2 weeks before the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum CD4+ T cell count After 6 weeks of treatment Flow cytometry (BD FACSCalibur) with BD Reagent,Serum CD8+ T cell count After 6 weeks of treatment Flow cytometry (BD FACSCalibur) with BD Reagent,Fecal sIgA level After 6 weeks of treatment Solid phase direct ELISA sandwich method from Calbiotech ,T helper 1 based on interferon-gamma After 6 weeks of treatment ELISA method using blood sample,T helper 2 based on IL-4 After 6 weeks of treatment ELISA method using blood sample,T helper 17 based on IL-17 After 6 weeks of treatment ELISA method using blood sample,Treg based on TGF-beta ELISA method using blood sample ELISA method using blood sample,Blood lipopolysaccaride After 6 weeks of treatment Limulus Amebocyte Lysate ELISA method using blood sample,Fecal calprotectin After 6 weeks of treatment ELISA method using feces sample
- Secondary Outcome Measures
Name Time Method /A N/A N/A