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Effect of Lactobacillus Plantarum IS-10506 supplementation on systemic and humoral mucosal immune responses in children with HIV infection with antiretroviral therapy

Effect of Lactobacillus Plantarum IS-10506 supplementation on systemic and humoral mucosal immune responses in children with HIV infection with antiretroviral therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180525003
Enrollment
Unknown
Registered
2018-05-25
Start date
2012-03-12
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Children with HIV infection with antiretroviral therapy HIV infected children antiretroviral L.plantarum IS&#45

Interventions

Subjects were classified into 2 groups: probiotic group (A) received 700 mg microencapsulated probiotic 1010 cfu/day and standard HIV therapy&#44
and placebo group (B) that received 700 mg placebo (skim milk)/day and standard HIV therapy for 6 weeks intervention. Microencapsulated Lactobacillus plantarum IS&#45
10506 (Gene Bank Accession number DQ860148) powder was prepared by cultivating in a fermentor on MRS broth&#44
at 37 degrees Celcius for 20 hours&#44
120 rpm&#44
harvested by cool centrifuged at 4 degrees Celcius for 10 minutes&#44
3500 rpm&#44
washed twice with PBS saline (pH 6.8)&#44
the culture paste was frozen in liquid nitrogen and kept at &#45
80 degrees Celcius prior to dry with Fluid bed top spray coating methods. The paste was thawed&#44
dissolved in UHT milk added with Avicel PH 101&#44
maltodextrin as a carrier&#44
mixed&#44
homogenized&#44
extruded and spheronized at 1300 rpm for 5 seconds&#44
dried at 30oC for 30 minutes&#44
and coated with Sodium alginate washed with aquadest&#44
and calcium chloride&#44
at 30 degrees Celcius for 30 minutes each&#44
then dried at 30 degrees Celcius for 30 minutes&#44

Sponsors

Faculty of Medicine, Universitas Airlangga
Lead Sponsor
Faculty of Medicine&#44
Collaborator
Universitas Airlangga
Collaborator

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

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

Exclusion criteria: Infected HIV children that withdrew antiretroviral therapy Receiving probiotic supplementation 2 weeks before the study

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
N/A N/A N/A

Countries

Indonesia

Contacts

Public ContactAlpha Athiyyah

Universitas Airlangga

alpha-f-a@fk.unair.ac.id+628123585507

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026