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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
Karolinska University Hospital
Information provided by (Responsible Party):
MariusTrøseid, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Dietary Supplement: Multi-strain probiotic Dietary Supplement: Placebo Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
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
No intervention

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

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Oslo University Hospital
Oslo, Norway, 0407
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Oslo University Hospital
Karolinska University Hospital
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Study Director: Geir Gokstad, MD, PhD Oslo University Hospital
Principal Investigator: Marius Trøseid, MD, PhD Oslo University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MariusTrøseid, Marius Trøseid, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01439841    
Other Study ID Numbers: ProGut1.0
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Keywords provided by MariusTrøseid, Oslo University Hospital:
microbial translocation
immune activation
Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases