The prospective pilot trial for evaluating the effects of probiotics on the clinical course of the HIV-1-infected children on ART and ART naive at National Hospital of Pediatrics in Hanoi, Vietnam

The prospective pilot trial for evaluating the effects of probiotics on the clinical course of the HIV-1-infected children on ART and ART naive at National Hospital of Pediatrics in Hanoi, Vietnam - The efficacy of probiotics on the immune status of HIV-infected-children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015044

Enrollment

Registered

2014-09-03

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Human immunodeficiency virus type 1 (HIV-1) infection

Interventions

Group 1: HIV-1 infection (+), ART (-) Interventions: Ingest 65ml of LcS containing substrate (Yakult), everyday for 8 weeks. Group 2: HIV-1 infection (+), ART (+) Interventions: Ingest 65ml of LcS c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Intervention group 1 and 2: (1) HIV-1-infected children following at National Pediatric Hospital (NHP), Hanoi, Vietnam (2) whose guardians are informed and consent to participate in this trial. (3) who can follow the trial protocol. - Intervention group 3: (1) whose guardians are informed and consent to participate in this trial. (2) who can follow the trial protocol.

Exclusion criteria

Exclusion criteria: - Intervention group 1 and 2: (1) whose status are Acquired immune deficiency syndrome, AIDS (2) who have symptoms of intestinal infection. (3) who have had any treatment which might influence on her/his immune system within last eight weeks of starting to take test substance. (4) who are allergic to milk - Intervention group 3: (1) who have symptoms of intestinal infection. (2) who have had any treatment which might influence on her/his immune system within last eight weeks of starting to take test substance. (3) who are allergic to milk

Design outcomes

Primary

Measure	Time frame
The concentration of the plasma 16SrDNA/RNA before and after the ingestion of LCS	—

Secondary

Measure	Time frame
- The concentration of the plasma soluble CD14 - The plasma HIV load - The plasma CD4 count - The concentration of the plasma cytokines - The profile of the CD25/CD4 ratio on PBMC	—

Countries

Asia(except Japan)

Contacts

Public ContactHiroshi ICHIMURA

Graduate school of Medical Sciences, Kanazawa University Department of Viral infection and International Health

ichimura@med.kanazawa-u.ac.jp+81-76-265-2229

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026