The Effect of Probiotics in HIV-1 Infection (ProGut)
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|ClinicalTrials.gov Identifier: NCT01439841|
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Dietary Supplement: Multi-strain probiotic Dietary Supplement: Placebo||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Probiotics on Microbial Translocation and Immune Activation in HIV-1 Infection. A Randomised Placebo-controlled Trial|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||June 2013|
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.
Dietary Supplement: 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
Other Name: Brand name Biola®
Placebo Comparator: Placebo
Fermented and subsequently heat-treated, sterile skimmed milk (TINE SA) as active placebo.
Dietary Supplement: Placebo
Fermented and subsequently heat-treated, sterile skimmed milk
No Intervention: Control
- Safety [ Time Frame: 2 months ]Adverse events monitoring during the study period of 2 months
- 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)
- 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)
- 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)
- Immune reconstitution in ART treated patients [ Time Frame: 2 months ]Changes in CD4 count from baseline to 2 months (end of study)
- Gut microbiota composition [ Time Frame: 2 months ]Changes in gut microbiota (454 pyrosequencing of fecal samples) from baseline to 2 months (end of study)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439841
|Oslo University Hospital|
|Oslo, Norway, 0407|
|Karolinska University Hospital Huddinge|
|Stockholm, Sweden, 14186|
|Study Director:||Geir Gokstad, MD, PhD||Oslo University Hospital|
|Principal Investigator:||Marius Trøseid, MD, PhD||Oslo University Hospital|