Randomized Placebo-controlled Pilot Trial of Prebiotics+Glutamine in HIV Infection (MicroVIH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|