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

Rigshospitalet

Status: Completed

Conditions: HIV

Treatments: Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02764684

43771

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

HIV-infected patients

Experimental group

Description:

Probiotics (lactobacillus rhamnosus)

Treatment:

Drug: Probiotic