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NCT Number: NCT01439841

The Effect of Probiotics in HIV-1 Infection

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Oslo, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-strain probiotic

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

Other names: Brand name Biola®

Placebo

Dietary Supplement

Fermented and subsequently heat-treated, sterile skimmed milk

Primary outcomes

  1. Safety

    Time frame: 2 months

    Adverse events monitoring during the study period of 2 months

  2. Changes in measures of microbial translocation

    Time frame: 2 months

    Changes in plasma leves of lipopolysaccharide (LPS) and soluble CD14 from baseline to 2 months (end of study)

  3. Changes in markers of immune activation

    Time frame: 2 months

    Changes in CD38, HLA-DR and PD-1 on CD8+ and CD4+ T cells from baseline to 2 months (end of study)

Secondary outcomes

  1. Disease progression in untreated patients

    Time frame: 2 months

    Changes in CD4 count, viral load, clinical events and indication for ART from baseline to 2 months (end of study)

  2. Immune reconstitution in ART treated patients

    Time frame: 2 months

    Changes in CD4 count from baseline to 2 months (end of study)

  3. Gut microbiota composition

    Time frame: 2 months

    Changes in gut microbiota (454 pyrosequencing of fecal samples) from baseline to 2 months (end of study)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Karolinska University Hospital
  • Tine

Registry information

Official study title

The Effect of Probiotics on Microbial Translocation and Immune Activation in HIV-1 Infection. A Randomised Placebo-controlled Trial

Acronym: ProGut

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2011
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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