HIV
Conditions
Brief summary
Objective: In this study the investigators aim at investigating: 1. probiotics ability to modulate the microbiome and microbial translocation, 2. if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and 3. 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.
Interventions
DRUGProbiotic
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.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention | Will be measured before and after eight weeks of intervention. | will be measured in plasma samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention. | Will be measured before and after eight weeks of intervention. | will be measured in plasma samples |
| 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) | Will be measured before and after eight weeks of intervention. | positron emission tomography-magnetic resonance scans of the abdomen before an after intervention |
| Changes in of high sensitive C-reactive protein (unit mg/l) from baseline and after eight weeks of intervention | Will be measured before and after eight weeks of intervention. | will be measured in plasma samples |
| Changes in measures of cytokines unit (pg/ml) at baseline and after eight weeks of intervention | Will be measured before and after eight weeks of intervention. | will be measured in plasma samples |
| Changes in the gut microbiota composition (454 pyrosequencing of fecal samples) from baseline to eight weeks after intervention (end of study) | Will be measured before and after eight weeks of intervention. | stool-samples will be collected an analyzed by deep sequencing |
Countries
Denmark
Outcome results
None listed