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The Effect of Probiotics in HIV-1 Infection

NCT ID: NCT01439841

Last Updated: 2017-09-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-06-30

Brief Summary

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HIV progression is closely associated with chronic immune activation driven by leakage of bacterial products from a damaged gut, the investigators largest immunological organ. Notably, the degree of immune activation has been suggested to be a better predictor of disease progression than plasma viral load, and markers of immune activation and gut damage have been identified as therapeutic targets per se. The major damage by HIV to the immune system is an initial massacre of gut mucosal CD4+ Th17 cells. Interestingly, a normal gut flora has been shown to induce the maturation of Th17 cells in the small intestine mucosa. Preliminary reports have shown that the gut flora is altered in HIV-1 infection compared to controls. In this project, the investigators will characterize microbial composition of gut flora in chronic HIV infection with ultradeep sequencing. Gut flora composition will be related to clinical data as well as quantitative data of circulating microbial products and activation markers. Second, in a randomized clinical trial (RCT) the effect of probiotic lactobacilli on HIV pathogenesis and progression will be tested. This Gram-positive strain is clinically tested and is able to colonize the gut.

Detailed Description

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Objectives:

To explore (i) the safety and tolerability, and (ii) the efficacy of probiotics on HIV-associated microbial translocation, systemic immune activation, disease progression and composition of gut microbiota in chronic HIV-1 infection.

Methodology/Study design:

Approximately 50 patients without current indication for antiretroviral treatment (ART) and 50 patients receiving ART without normalised CD4 counts will be included. A controlled clinical trial will be carried out within each stratum randomised in a 2:1:1 fashion to double blinded intervention and placebo arms as well as an open, untreated control arm, respectively.

Conditions

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HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotics

A multi-strain Probiotic consisting of Lactobacillus rhamnosus GG, Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12 added to fermented skimmed milk (Biola®, TINE SA, Oslo), 250 mL/day for 8 weeks.

Group Type EXPERIMENTAL

Multi-strain probiotic

Intervention Type DIETARY_SUPPLEMENT

The product consists of Lactobacillus rhamnosus GG, Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12 added to fermented skimmed milk

Placebo

Fermented and subsequently heat-treated, sterile skimmed milk (TINE SA) as active placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Fermented and subsequently heat-treated, sterile skimmed milk

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multi-strain probiotic

The product consists of Lactobacillus rhamnosus GG, Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12 added to fermented skimmed milk

Intervention Type DIETARY_SUPPLEMENT

Placebo

Fermented and subsequently heat-treated, sterile skimmed milk

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Brand name Biola®

Eligibility Criteria

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Inclusion Criteria

* For patients without ART: Confirmed diagnosis of HIV infection \> 6 months and CD4+ T cell count \< 900
* For patients on stable, effective ART: HIV RNA \< 50 copies/ml \> 6 months and CD4+ T cell count \> 500
* Signed informed consent.

Exclusion Criteria

* Severe illness requiring hospitalization
* Systemic antibiotics or probiotics the last two months
* Current immune modulating therapy
* Infectious diarrhea
* Inflammatory bowel disease
* Acute primary HIV infection
* Patients immigrating from Africa, Asia or Latin-America within the last 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Tine

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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MariusTrøseid

Marius Trøseid, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geir Gokstad, MD, PhD

Role: STUDY_DIRECTOR

Oslo University Hospital

Marius Trøseid, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Site Status

Countries

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Norway Sweden

References

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Stiksrud B, Nowak P, Nwosu FC, Kvale D, Thalme A, Sonnerborg A, Ueland PM, Holm K, Birkeland SE, Dahm AE, Sandset PM, Rudi K, Hov JR, Dyrhol-Riise AM, Troseid M. Reduced Levels of D-dimer and Changes in Gut Microbiota Composition After Probiotic Intervention in HIV-Infected Individuals on Stable ART. J Acquir Immune Defic Syndr. 2015 Dec 1;70(4):329-37. doi: 10.1097/QAI.0000000000000784.

Reference Type DERIVED
PMID: 26258571 (View on PubMed)

Other Identifiers

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ProGut1.0

Identifier Type: -

Identifier Source: org_study_id