Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection (MicroVIH)
|ClinicalTrials.gov Identifier: NCT01838915|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Dietary Supplement: Prebiotics+Glutamine Dietary Supplement: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Gut Microbiota, Bacterial Translocation, Immune Activation and Endothelial Dysfunction in HIV Infection|
|Actual Study Start Date :||January 10, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
|Experimental: Dietary Supplement: Prebiotics+Glutamine||
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.
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
Maltodextrin, 20 g.
- Safety [ Time Frame: 6 weeks ]Adverse events monitoring during the intervention
- Changes in markers of bacterial translocation [ Time Frame: 6 weeks ]Soluble CD14 and increasing permeability binding protein.
- Changes in markers of immunoactivation [ Time Frame: 6 weeks ]Changes in percentages of CD4+ and CD8+ T-cells expressing CD25, HLADR, CD38.
- Changes in inflammatory markers [ Time Frame: 6 weeks ]Changes in interleukine-6 and high-sensitivity C Reactive Protein
- Changes in markers of endothelial dysfunction [ Time Frame: 6 weeks ]Changes in asymmetric dimethylarginine and flow-mediated dilation
- Changes in gut microbiota composition [ Time Frame: 6 weeks ]Changes in gut microbiota as determined by 454 pyrosequencing.
- Changes in gut microbiota [ Time Frame: 6 weeks ]Changes in gut microbiota by 454 pyrosequencing of fecal samples.
- Disease progression in HIV-infected patients. [ Time Frame: 6 weeks ]Levels of CD4+ T-cell and HIV-1 RNA copies/mL
- Thymic function [ Time Frame: 6 weeks ]
- Gene expression in peripheral blood monocytic cells. [ Time Frame: 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838915
|Hospital Ramón y Cajal and Hospital Clínico San Carlos|
|Madrid, Spain, 28034|