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

Primary Purpose

HIV

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Probiotic

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIV-infected patients

Arm Description

Probiotics (lactobacillus rhamnosus)

Outcomes

Primary Outcome Measures

change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention

will be measured in plasma samples

Secondary Outcome Measures

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

will be measured in plasma samples

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

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

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

will be measured in plasma samples

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

Full Information

NCT ID

NCT02764684

First Posted

November 4, 2015

Last Updated

October 9, 2016

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02764684

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Objective: In this study the investigators aim at investigating: probiotics ability to modulate the microbiome and microbial translocation, if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIV-infected patients

Arm Type

Experimental

Arm Description

Probiotics (lactobacillus rhamnosus)

Intervention Type

Drug

Intervention Name(s)

Probiotic

Other Intervention Name(s)

Lactobacillus rhamnosus

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention

Description

will be measured in plasma samples

Time Frame

Will be measured before and after eight weeks of intervention.

Secondary Outcome Measure Information:

Title

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

Description

will be measured in plasma samples

Time Frame

Will be measured before and after eight weeks of intervention.

Title

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)

Description

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.

Title

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

Description

will be measured in plasma samples

Time Frame

Will be measured before and after eight weeks of intervention.

Title

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

Description

will be measured in plasma samples

Time Frame

Will be measured before and after eight weeks of intervention.

Title

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

Description

stool-samples will be collected an analyzed by deep sequencing

Time Frame

Will be measured before and after eight weeks of intervention.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne D Nielsen, MD, DMSc

Organizational Affiliation

Rigshospitalet, danmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The investigator plan to publish data in an article when the study is completed

Learn more about this trial

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

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