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

P

Parc de Salut Mar

Status and phase

Unknown
Phase 2

Conditions

HIV -1 Infection

Treatments

Dietary Supplement: Probiotic.
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01908049
PROB-VIH

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups, including a placebo group

Probiotic
Experimental group
Description:
A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks.
Treatment:
Dietary Supplement: Probiotic.
Placebo
Placebo Comparator group
Description:
No active substance is given.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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