The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients
Overview
- Phase
- Not Applicable
- Intervention
- Probiotic
- Conditions
- HIV
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
Susanne Dam Nielsen, MD
Associate Professor
Rigshospitalet, Denmark
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
- •Inflammatory bowel disease
- •autoimmune diseases
Arms & Interventions
HIV-infected patients
Probiotics (lactobacillus rhamnosus)
Intervention: Probiotic
Outcomes
Primary Outcomes
change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention
Time Frame: Will be measured before and after eight weeks of intervention.
will be measured in plasma samples
Secondary Outcomes
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)