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

NCT01908049 | Unknown Phase 2

• 1 other identifier: PROB-VIH
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV -1 Infection

Keywords

Probiotic; HIV; Microbial translocation; inflammation; microbiota composition

Outcome Measures

Primary Outcomes (2)

• To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP).

  From randomisation to 6 months.

• To evaluate Gut microbiota composition.

  Change in gut microbiota (454 pyrosequencing of fecal samples).

  From randomisation to 6 months.

Secondary Outcomes (2)

• 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.

  From randomisation to 6 months.

• Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load.

  From randomisation to 6 months.

Study Arms (2)

Probiotic

EXPERIMENTAL

A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.

Dietary Supplement: Probiotic.

Placebo

PLACEBO COMPARATOR

No active substance is given.

Dietary Supplement: Placebo

Interventions

Probiotic. DIETARY_SUPPLEMENT

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (1)

• Villar-Garcia J, Hernandez JJ, Guerri-Fernandez R, Gonzalez A, Lerma E, Guelar A, Saenz D, Sorli L, Montero M, Horcajada JP, Knobel Freud H. Effect of probiotics (Saccharomyces boulardii) on microbial translocation and inflammation in HIV-treated patients: a double-blind, randomized, placebo-controlled trial. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):256-63. doi: 10.1097/QAI.0000000000000468.

  PMID: 25469528 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 25, 2013
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2017
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

ES (1)