HIV Infections Clinical Trial
Official title:
The Role of Probiotics L. Plantarum, S. Thermophiles, B. Bifidum on Gut Inflammation, Bacterial Translocation, and CD4+ Cell Count in HIV Patients With Immunological Non-Responder
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.
HIV patients could develop immunological failure despite being treated with antiretroviral
therapy (ART). Thus resulting the increase of morbidity and mortality among HIV patients,
especially in Indonesia. The immunological failure is associated with decreased gut integrity
and immunity, increased gut inflammation, and gut bacterial translocation to the blood.
Memory CD4+ T cell damage in gut associated lymphoid tissue (GALT) by HIV-1 virus leads to
decreased production of Th17 in gut mucosal layer. Furthermore, low level of Th17 facilitates
bacterial translocation in HIV patients.
Probiotic supplementation (Lactobacillus) could decrease the gut inflammation in some
diseases including HIV infection; thus helps increasing the gut integrity and immunity by
repairing the gut mucosal tight junction, increasing mucin production, and regulating gut
Th17. As a result, the gut inflammation and bacterial translocation decreases. Nevertheless,
the benefit in HIV patients with immunological non responder status has not been established.
The investigators plan to perform double blind randomized clinical trial of probiotics
(containing Lactobacillus plantarum, Streptococcus thermophiles, Bifidobacterium bifidum) in
HIV patients with immunological non responder status. The Subject who fulfill inclusion
criteria, willing to participate and sign informed consent will be randomized into two
groups: the group receiving probiotics (n=40) and the group of placebo (n=40). Intervention
will be held for 12 weeks. This study will evaluate the gut mucosal integrity and immunity by
Th17 measurement; bacterial translocation by 16S ribosomal RNA (16S RNA) measurement; and gut
inflammation by fecal calprotectin measurement before and after the intervention. Moreover,
the investigators will measure the CD4+ level to assess immune status recovery before and
after the intervention. Side effects, HIV symptom index, Food Frequency Questionnaire will
also be assessed every 4 weeks.
Statistical analysis will uses: paired and independent t test (if normally distributed) or
using Wilcoxon and Mann Whitney test (if not normally distributed). HIV symptom index and
Food frequency will be reported descriptively.
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