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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV-infected patients; Probiotics (lactobacillus rhamnosus)	Drug: Probiotic; 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.; 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.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Susanne D Nielsen, MD, DMSc, Rigshospitalet, danmark

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 11, 2016
• Last Update Submitted That Met QC Criteria: October 9, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 43771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigator plan to publish data in an article when the study is completed