Phase 2 Completed N=80 Randomized Double-blind Treatment

The Role of Probiotics in HIV Patients With Immunological Non-Responder

HIV · Immunological Abnormality

Source: ClinicalTrials.gov NCT03568812 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcomePrimary: CD4+ Level — 162.3; 50.5; 143.3; 69.9 cell/μL — p=0.02

Summary

This study will address HIV patients who are on antiretroviral treatment (ART) and experiencing immunological failure. The cause of immunological failure in HIV patients could be due to several factors such as age, gender, Cluster of Differentiation (CD4)+ count before started treatment and some inflammation in the gut. The C-C Chemokine Receptor 5 (CCR5) receptor on T lymphocyte CD4+ are abundantly found in the gut and attacked by HIV virus during acute infection causing irreversible damage. The disruption of gut integrity and chronic inflammation further causing translocation of bacteria in gut lumen to the blood. Thus resulting persistent low CD4+ or immunological failure. This evaluation plan is designed to establish the role of investigation product (probiotics) to improve gut inflammation in HIV patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY CD4+ Level	162.3; 50.5; 143.3; 69.9	0.02 sig
SECONDARY Th17 Level Change	-0.5; -0.2; -0.3; -0.4	0.55
SECONDARY 16S Ribosomal RNA (rRNA) Total	NA; NA	—
SECONDARY Fecal Calprotectin Level Change	-4.3; 8.4; -5.8; 9.9	0.03 sig
SECONDARY Amount of Participants With HIV Related Symptoms	-1.6; -1.3; -1.4; -1.11; -0.6; -0.1	—

Eligibility Criteria

Inclusion Criteria

HIV patient with immunological non-responder status which defined as:
first line antiretroviral therapy (ART) treated for minimal 6 months
CD4+ level between 200-410 cell/μL
HIV viral load <34 copies/mL
giving consent to participate the study

Exclusion Criteria

being pregnant
lactating
known Lactobacillus allergy
BMI <16 kg/m2
under Tuberculosis treatment or other acute illness
acute diarrhea
routinely taking selenium containing vitamin in last 1 month
routinely consuming probiotics containing product in last 1 month

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03568812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.