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

NCT02764684 | Completed DMC

• 1 other identifier: 43771
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: In this study the investigators aim at investigating:

1. 1.probiotics ability to modulate the microbiome and microbial translocation,
2. 2.if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and
3. 3.if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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.

• 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.

Study Arms (1)

HIV-infected patients

EXPERIMENTAL

Probiotics (lactobacillus rhamnosus)

Drug: Probiotic

Interventions

Probiotic DRUG

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.

Also known as: Lactobacillus rhamnosus

HIV-infected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18
• confirmed HIV
• no HIV treatment
• cluster of differentiation 4+ cell count over 350

You may not qualify if:

• antibiotic or probiotic in last 2 month
• drugs that influence gut motility
• diabetes
• Inflammatory bowel disease
• cancer
• autoimmune diseases

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Susanne D Nielsen, MD, DMSc

  Rigshospitalet, danmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: May 6, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)