NCT01838915

Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection

Gut Microbiota, Bacterial Translocation, Immune Activation and Endothelial Dysfunction in HIV Infection

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A rapid and almost complete loss of CD4+ T cells from the gut associated lymphoid tissue (GALT) occurs early in HIV infection, with a permanent damage in the intestinal barrier, changes in gut microbiota, increased bacterial translocation and persistent immune activation, changes that are not restored after the initiation of antiretroviral therapy. The investigators hypothesize than an intervention targetting the enterocyte barrier and the gut microbiota might modify the gastrointestinal tract towards a bifidogenic microbiota and improve markers of bacterial translocation, inflammation, immune activation and endothelial dysfunction.

Detailed description

This is a randomized placebo-controlled clinical trial to evaluate the safety and effectiveness to modify gut microbiota, bacterial translocation, immune activation and markers of endothelial dysfunction of a dietary supplement (prebiotics + glutamine) during a period of six weeks. The study will enroll four cohorts: 1) HIV-infected, treatment naive individuals; 2) HIV-infected subjects, currently on ART, with \>350 CD4+ T-cells/uL; 3) HIV-infected subjects, currently on ART, with \<350 CD4+ T-cells/uL; 4) HIV negative healthy controls.

Conditions

• HIV

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotics+Glutamine	Prebiotics are nondigestible food ingredients, generally oligosaccharides, that modify intestinal microbiota balance by stimulating the growth of beneficial bacteria. Glutamine is a non-essential amino acid that can be metabolized by epithelial cells, enhancing barrier function.
DIETARY_SUPPLEMENT	Placebo	Maltodextrin, 20 g.

Timeline

• Start date: 2017-01-10
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2013-04-24
• Last updated: 2019-02-11

Locations

1 site across 1 country: Spain