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

HIV Clinical Trial

— RECOVER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542786
• Other study ID #: I3.1 IRSICAIXA
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: February 29, 2020

Study information

• Verified date: July 2020
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging, Premature
• HIV
• Premature Aging

Intervention

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
• 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
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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
AB Biotics, SA	Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).