NCT03542786

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• HIV
• Premature Aging

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2017-12-18
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2018-05-31
• Last updated: 2020-07-08

Locations

1 site across 1 country: Spain