HIV, Premature Aging
Conditions
Keywords
HIV-1
Brief summary
The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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
DIETARY_SUPPLEMENTPrebiotic
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
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Germans Trias i Pujol Hospital
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
100 patients will be included in this trial. Patients will be randomized 2: 2: 1 to one of the following 3 branches according to the use of integrase inhibitors (INI), protease inhibitors (PI) or non-nucleoside analogue reverse transcriptase inhibitors ( ITINAN) and according to the CD4 count nadir is greater or less or equal to 200 cells / mm3: Branch A: add probiotic i3.1 to the antiretroviral therapy Branch B: add probiotic i3.1 and ProSeed prebiotic to the antiretroviral therapy Branch C: add placebo to ART The treatment periods will be of 6 months and follow-up will be carried out at month, at 3 months and at 6 after the start of the study treatment, and a last visit will be made at 3 months after discontinuing it (wash-out period).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The appearance of adverse effects. | Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively). | Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Translocational bacterial markers & Systemic inflammation markers | A measure will be made in V1 and V2 (1 month and 3 months after the treatment beginning, respectively). | 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. |
| Cluster of Differentation 4 (CD4) count | A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively). | Recount changes (cells/mm3) among the basal visit and 3 months after, in each arm. |
| CD4/CD8 ratio | A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively). | Ratio changes among the basal visit and 3 months after, in each arm. |
| Gut microbiota diversity and metabolomic profile | 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). | Biodiversity changes among the basal visit and 3 months after (in each arm), measured using the Shannon Index. |
| Questionaire to evaluate the life quality | A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively). | This parameter will be measured with the Medical Outcomes Study-HIV questionaire (with answers from not affected to affected). |
| Questionaires to evaluate the anxiety and depression | A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively). | This parameter will be measured with the Hospital Anxiety Depression Scale (HADS) questionaire (with answers from never to always). |
| Satisfaction with the product | A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively). | 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). |
Countries
Spain
Outcome results
None listed