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

Sponsor

AB Biotics, SA (Industry)

Overall Status

Completed

CT.gov ID

NCT03542786

Collaborator

Germans Trias i Pujol Hospital (Other)

Enrollment

Location

Arms

26.4

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

89 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).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 :

Dec 18, 2017

Actual Primary Completion Date :

Feb 29, 2020

Actual Study Completion Date :

Feb 29, 2020

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain	08916

Sponsors and Collaborators

AB Biotics, SA
Germans Trias i Pujol Hospital

Investigators

Study Director: Ariana Salavert, PhD, AB-Biotics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AB Biotics, SA

ClinicalTrials.gov Identifier:

NCT03542786

Other Study ID Numbers:

I3.1 IRSICAIXA

First Posted:

May 31, 2018

Last Update Posted:

Jul 8, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by AB Biotics, SA

HIV-1

Additional relevant MeSH terms:

Aging, Premature

Study Results

No Results Posted as of Jul 8, 2020