The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients

Study Overview
=================
Brief Summary
-----------------
Objective: In this study the investigators aim at investigating: probiotics ability to modulate the microbiome and microbial translocation, if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract. Design: The study is a prospective clinical intervention trial of 40 HIV-infected patients. Method: The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.

Official Title
-----------------
The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 confirmed HIV no HIV treatment cluster of differentiation 4+ cell count over 350 Exclusion Criteria: antibiotic or probiotic in last 2 month drugs that influence gut motility diabetes Inflammatory bowel disease cancer autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV-infected patients<br>Probiotics (lactobacillus rhamnosus) | Drug: Probiotic<br>* The probiotic strain Lactobacillus rhamnosus will be self-administrated twice a day, one capsule in the morning and one in the evening for eight weeks.<br>* Other names: Lactobacillus rhamnosus;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention | will be measured in plasma samples | Will be measured before and after eight weeks of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention. | will be measured in plasma samples | Will be measured before and after eight weeks of intervention. | 
| change in inflammation around the gut measured with positron emission tomography-magnetic resonance scans of the abdomen ( size of the lymph nodes and positron emission tomography-activity) | positron emission tomography-magnetic resonance scans of the abdomen before an after intervention | Will be measured before and after eight weeks of intervention. | 
| Changes in of high sensitive C-reactive protein (unit mg/l) from baseline and after eight weeks of intervention | will be measured in plasma samples | Will be measured before and after eight weeks of intervention. | 
| Changes in measures of cytokines unit (pg/ml) at baseline and after eight weeks of intervention | will be measured in plasma samples | Will be measured before and after eight weeks of intervention. | 
| Changes in the gut microbiota composition (454 pyrosequencing of fecal samples) from baseline to eight weeks after intervention (end of study) | stool-samples will be collected an analyzed by deep sequencing | Will be measured before and after eight weeks of intervention. |