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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT02764684
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
20
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    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) [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 [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 [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) [Will be measured before and after eight weeks of intervention.]

      stool-samples will be collected an analyzed by deep sequencing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susanne Dam Nielsen, MD, Associate Professor, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT02764684
    Other Study ID Numbers:
    • 43771
    First Posted:
    May 6, 2016
    Last Update Posted:
    Oct 11, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Inflammation

    Study Results

    No Results Posted as of Oct 11, 2016