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

Overview

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

Full Title of Study: “Clinical Trial, Randomized and Controlled With Placebo to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic, Only or in Conjunction of a Pre-biotical, in Adults Infected by Hiv-1 With a cd4 Record Less Than 500 Cells / mm3”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 29, 2020

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 Supplement: Probiotic
    • 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 Supplement: Prebiotic
    • 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 Supplement: Placebo
    • 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.

Arms, Groups and Cohorts

  • Experimental: i3.1
    • This group will have their habitual antiretroviral therapy (integrase inhibitor (INI), protease inhibitor (IP), reverse transcriptase inhibitor (ITINAN)) combined with the research product (probiotic i3.1). The prebiotic will be taken once a day during 6 months.
  • Experimental: i3.1 + ProSeed
    • This group will have their habitual antiretroviral therapy combined with the probiotic (i3.1) and the prebiotic (ProSheed). The prebiotic and probiotic will be taken once a day during 6 months.
  • Placebo Comparator: Placebo
    • This group will only have their habitual antiretroviral therapy. The placebo will be taken once a day during 6 months.

Clinical Trial Outcome Measures

Primary Measures

  • The appearance of adverse effects.
    • Time Frame: 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 Measures

  • Gut microbiota diversity and metabolomic profile
    • 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).
    • Biodiversity changes among the basal visit and 3 months after (in each arm), measured using the Shannon Index.
  • Translocational bacterial markers & Systemic inflammation markers
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.
  • Satisfaction with the product
    • Time Frame: 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).
  • Questionaire to evaluate the life quality
    • Time Frame: 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
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AB Biotics, SA
  • Collaborator
    • Germans Trias i Pujol Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ariana Salavert, PhD, Study Director, AB-Biotics

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