The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients
NCT ID: NCT02764684
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2015-01-31
2016-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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HIV-infected patients
Probiotics (lactobacillus rhamnosus)
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmed HIV
* no HIV treatment
* cluster of differentiation 4+ cell count over 350
Exclusion Criteria
* drugs that influence gut motility
* diabetes
* Inflammatory bowel disease
* cancer
* autoimmune diseases
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Susanne Dam Nielsen, MD
Associate Professor
Principal Investigators
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Susanne D Nielsen, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, danmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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43771
Identifier Type: -
Identifier Source: org_study_id
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