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Completed

NCT Number: NCT03542786

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

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

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Key information

Conditions

HIV Aging, Premature Pathological Conditions, Signs and Symptoms Premature Aging Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary 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

Prebiotic

Dietary 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

Placebo

Dietary 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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Collaborators

  • Germans Trias i Pujol Hospital

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 31, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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