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

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ClinicalTrials.gov Identifier: NCT03542786
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
AB Biotics, SA

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

Condition or disease Intervention/treatment Phase
HIV Premature Aging Dietary Supplement: Probiotic Dietary Supplement: Prebiotic Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542786


Contacts
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Contact: Ariana Salavert, PhD 935946024 salavert@ab-biotics.com

Locations
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Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Cristina Herrero       cherrero@fls-rs.com   
Sponsors and Collaborators
AB Biotics, SA
Germans Trias i Pujol Hospital
Investigators
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Study Director: Ariana Salavert, PhD AB-Biotics

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Responsible Party: AB Biotics, SA
ClinicalTrials.gov Identifier: NCT03542786     History of Changes
Other Study ID Numbers: I3.1 IRSICAIXA
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AB Biotics, SA:
HIV-1

Additional relevant MeSH terms:
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Aging, Premature
Signs and Symptoms
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents