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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Drug: Probiotic

• Registration Number: NCT02764684
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-09
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIV-infected patients	Probiotic	Probiotics (lactobacillus rhamnosus)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark