An interventional study of Probiotic in HIV, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-11.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Prevention
Objective:
In this study the investigators aim at investigating:
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.
3,438 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 2,436 interventional studies indexed under Inflammation.
Browse Inflammation studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Lactobacillus rhamnosus
change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention
will be measured in plasma samples
Time frame: Will be measured before and after eight weeks of intervention.
change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention.
will be measured in plasma samples
Time frame: 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)
positron emission tomography-magnetic resonance scans of the abdomen before an after intervention
Time frame: 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 in plasma samples
Time frame: 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 in plasma samples
Time frame: 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)
stool-samples will be collected an analyzed by deep sequencing
Time frame: Will be measured before and after eight weeks of intervention.
Plan to share: Yes — The investigator plan to publish data in an article when the study is completed
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark