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Completed

NCT Number: NCT02764684

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Lactobacillus rhamnosus

Primary outcomes

  1. 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

  1. change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention.

    Time frame: Will be measured before and after eight weeks of intervention.

    will be measured in plasma samples

  2. 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)

    Time frame: Will be measured before and after eight weeks of intervention.

    positron emission tomography-magnetic resonance scans of the abdomen before an after intervention

  3. Changes in of high sensitive C-reactive protein (unit mg/l) from baseline and after eight weeks of intervention

    Time frame: Will be measured before and after eight weeks of intervention.

    will be measured in plasma samples

  4. Changes in measures of cytokines unit (pg/ml) at baseline and after eight weeks of intervention

    Time frame: Will be measured before and after eight weeks of intervention.

    will be measured in plasma samples

  5. Changes in the gut microbiota composition (454 pyrosequencing of fecal samples) from baseline to eight weeks after intervention (end of study)

    Time frame: Will be measured before and after eight weeks of intervention.

    stool-samples will be collected an analyzed by deep sequencing

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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