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

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

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

Study Overview

• Status: Completed
• Conditions: HIV; Premature Aging
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Prebiotic; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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.	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
PLACEBO_COMPARATOR: Placebo; This group will only have their habitual antiretroviral therapy. The placebo will be taken once a day during 6 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The appearance of adverse effects.	Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo.	Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota diversity and metabolomic profile	Biodiversity changes among the basal visit and 3 months after (in each arm), measured using the Shannon Index.	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.	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.	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.	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).	A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Questionaire to evaluate the life quality	This parameter will be measured with the Medical Outcomes Study-HIV questionaire (with answers from not affected to affected).	A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Questionaires to evaluate the anxiety and depression	This parameter will be measured with the Hospital Anxiety Depression Scale (HADS) questionaire (with answers from never to always).	A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Collaborators: Germans Trias i Pujol Hospital
• Investigators: Study Director: Ariana Salavert, PhD, Ab-biotics

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2017
• Primary Completion (ACTUAL): February 29, 2020
• Study Completion (ACTUAL): February 29, 2020

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (ACTUAL): May 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HIV-1
• Additional Relevant MeSH Terms: Aging, Premature
• Other Study ID Numbers: I3.1 IRSICAIXA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No