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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764684
• Other study ID #: 43771
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: October 9, 2016
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention.	will be measured in plasma samples	Will be measured before and after eight weeks of intervention.	No
Secondary	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	Will be measured before and after eight weeks of intervention.	No
Secondary	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	Will be measured before and after eight weeks of intervention.	No
Secondary	Changes in measures of cytokines unit (pg/ml) at baseline and after eight weeks of intervention	will be measured in plasma samples	Will be measured before and after eight weeks of intervention.	No
Secondary	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	Will be measured before and after eight weeks of intervention.	No