Trial record 7 of 39 for:    " June 26, 2013":" July 26, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in HIV Infection.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01908049
First received: July 22, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition.

SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics.

Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.


Condition Intervention Phase
HIV -1 Infection
Dietary Supplement: Probiotic.
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in HIV Infection.

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP). [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: Yes ]
  • To evaluate Gut microbiota composition. [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: No ]
    Change in gut microbiota (454 pyrosequencing of fecal samples).


Secondary Outcome Measures:
  • To evaluate Markers of immune activity: soluble CD14 (sCD14), interferon gamma (IFN-Υ), tumor necrosis factor (TNF), IL-6, Reactive C protein, D -dimer, fibrinogen. [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: No ]
  • Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load. [ Time Frame: From randomisation to 6 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Study Start Date: August 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
Dietary Supplement: Probiotic.
Placebo Comparator: Placebo
No active substance is given.
Dietary Supplement: Placebo

  Eligibility

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

Inclusion Criteria:

  • Patients with chronic HIV infection and viral load undetectable > two years with stable ART CD4> 400 cells / ml.
  • Patients with chronic HIV infection and viral load undetectable> two years with stable ART CD4 <350 cells / ml.
  • Inform consent signed.
  • Aged between 18- No limit.

Exclusion Criteria:

  • Patients who receive or have received in the past 6 months food supplements containing probiotics.
  • Patients who have received antibiotic treatment in the last two months
  • Patients who are poor presupposes adherence to dietary supplements.
  • Patients who have changed the TAR in the last three months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908049

Contacts
Contact: Villar Garcia Judit, Dr. 0034 635505451 jvillar@parcdesalutmar.cat

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Villar Garcia Judit, Dr.    0034 635505451    jvillar@parcdesalutmar.cat   
Principal Investigator: Villar Garcia Judit, Dr.         
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01908049     History of Changes
Other Study ID Numbers: PROB-VIH
Study First Received: July 22, 2013
Last Updated: July 24, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Parc de Salut Mar:
Probiotic
HIV
Microbial translocation
inflammation
microbiota composition

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

ClinicalTrials.gov processed this record on August 20, 2014