Clinical Trial to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic

AB Biotics, SA89 enrolled

Overview

The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).

It's been demonstrated that the HIV-1 virus is associated to the reduction of the microbiota. Some studies suggest that because of this bacterial reduction, the premature aging appears. So this study aims to demonstrate that our probiotic can balance the microbiota as a preventive solution for the inflammaging.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV Premature Aging

Interventions

ProbioticDIETARY_SUPPLEMENT

The probiotic i3.1 is a commercialized product. It will be supplied by the promoter and manufactured in ALIFARM S.A. It contains: * Lactobacillus plantarum CECT7484 * Lactobacillus plantarum CECT7485 * Pediococcus acidilactici CECT7483

PrebioticDIETARY_SUPPLEMENT

ProSeed prebiotic is a non-commercialized product. It will be supplied by the promoter and manufactured in ALIFARM S.A. It contains: * Partially Hydrolyzed Guar Gum (PHGG) * Inulin HPD * Oat Beta-Glucans * Pectin * Inulin Low Protein Diet (LPD) * Polydextrose * Maltrodextrins

PlaceboDIETARY_SUPPLEMENT

It is a non-commercialized product. It is composed of the same excipients as the probiotic and the prebiotic. It will be supplied by the promoter and manufactured in ALIFARM S.A.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Older than 18 years old. * Documented HIV-1 infection. * Be in treatment with these antiretrovirals (INI, IP, ITINAN) during 12 months. * HIV-1 Viral titer \<50 copies/mL during 6 months. * CD4\> 500 cells/mm3. Exclusion Criteria: * Treatment with antibiotics. * Severe diseases actives. * Defining diseases of AIDS in the previous year. * Gut surgery except appendectomy or cholecystectomy. * Pregnancy. * Any diet deviation (vegans). * Other probiotic treatment.

Locations (1)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Outcomes

Primary Outcomes

The appearance of adverse effects.

Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo.

Time frame: Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).

Secondary Outcomes

Gut microbiota diversity and metabolomic profile

Biodiversity changes among the basal visit and 3 months after (in each arm), measured using the Shannon Index.

Time frame: A measure will be made in V1, V2, V3 and V4 (1 month, 3 months, 6 months and 9 months after the treatment beginning, respectively).

Translocational bacterial markers & Systemic inflammation markers

Markers changes among the basal visit and 3 months after, in each arm.The plasma levels of lipopolysaccharide, sCD14, Interleukin 6 and Iinterleukin 10 will be measured.

Time frame: A measure will be made in V1 and V2 (1 month and 3 months after the treatment beginning, respectively).

Cluster of Differentation 4 (CD4) count

Recount changes (cells/mm3) among the basal visit and 3 months after, in each arm.

Time frame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).

CD4/CD8 ratio

Ratio changes among the basal visit and 3 months after, in each arm.

Time frame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).

Satisfaction with the product

This parameter will be measured in order to evaluate the satisfaction of the patient with the research product. The satisfaction with the product wil be measured with the Likert Scale (with answers from satisfied to unsatisfied).

Data from ClinicalTrials.gov

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