Trial record 14 of 42 for:    " September 14, 2011":" October 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

The Effect of Probiotics in HIV-1 Infection (ProGut)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Karolinska University Hospital
TINE SA
Information provided by (Responsible Party):
MariusTrøseid, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01439841
First received: September 16, 2011
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
HIV-1 Infection
Dietary Supplement: Multi-strain probiotic
Dietary Supplement: Placebo
Other: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Adverse events monitoring during the study period of 2 months

  • Changes in measures of microbial translocation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Disease progression in untreated patients [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Changes in CD4 count from baseline to 2 months (end of study)

  • Gut microbiota composition [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Changes in gut microbiota (454 pyrosequencing of fecal samples) from baseline to 2 months (end of study)


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control group not receiving intervention.
Other: Control
No intervention

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439841

Contacts
Contact: Marius Trøseid, MD, PhD +4792440240 marius.troseid@medisin.uio.no
Contact: Dag Kvale, MD, PhD +4795200709 dag.kvale@medisin.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: Marius Troseid, MD, PhD    +4792440240    marius.troseid@medisin.uio.no   
Contact: Dag Kvale, MD, PhD    +4795200709    dag.kvale@medisin.uio.no   
Sub-Investigator: Dag Kvale, MD, PhD         
Principal Investigator: Marius Trøseid, MD, PhD         
Sweden
Karolinska University Hospital Huddinge Not yet recruiting
Stockholm, Sweden, 14186
Contact: Anders Sonnerborg, MD, PhD    +46736996240    anders.sonnerborg@ki.se   
Principal Investigator: Anders Sonnerborg, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
Karolinska University Hospital
TINE SA
Investigators
Study Director: Geir Gokstad, MD, PhD Oslo University Hospital
Principal Investigator: Marius Trøseid, MD, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: MariusTrøseid, Marius Trøseid, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01439841     History of Changes
Other Study ID Numbers: ProGut1.0
Study First Received: September 16, 2011
Last Updated: December 7, 2011
Health Authority: Norway: Directorate of Health
Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
HIV
microbial translocation
immune activation
probiotics

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014