Pilot Trial of a Synbiotic in HIV+ Patients

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00688311
First received: May 16, 2008
Last updated: November 19, 2009
Last verified: November 2009

May 16, 2008
November 19, 2009
May 2008
November 2009   (final data collection date for primary outcome measure)
Plasma Lipopolysaccharide [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00688311 on ClinicalTrials.gov Archive Site
Immune Activation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Trial of a Synbiotic in HIV+ Patients
Pilot Trial of a Synbiotic in HIV+ Patients

The goal of this study is to test the hypothesis that daily ingestion of a 'synbiotic' for 4 weeks will improve intestinal function, ease immune system overactivation, and increase blood CD4 count in HIV-infected individuals. A 'Synbiotic' is a mixture of probiotic bacteria and dietary fiber.

RATIONALE. HIV infection results in alterations to the intestinal tract, even in clinically healthy patients. Changes may include pronounced CD4 T-cell loss, enteric nerve and smooth muscle degeneration, abnormal enterocyte morphology, altered gene expression patterns, increased intestinal permeability, and decreased absorptive capacity. Recently it was found that HIV infection may also result in abnormal low-level leakage of lipopolysaccharide (LPS, a gram-negative bacterial product) from the gut into the circulation which promotes systemic immune activation. As immune activation is a strong positive correlate of HIV disease progression, it may be very important to develop effective means to improve intestinal barrier function in HIV infection. Evidence also exists that uninfected individuals of African descent may have higher intestinal permeability than uninfected Caucasians, suggesting that intestinal dysfunction in the event of HIV infection could differ between the two races. With regard to gender, women have been shown to display more pronounced inflammatory responses to LPS compared to men. Intriguing research outside the HIV field using animal models of compromised gut barrier function and also using human subjects with trauma- or disease-associated intestinal leakage has shown that oral administration of certain probiotic bacteria can 1) Reduce bacterial translocation, 2) Reduce bacterial infections, 3) Decrease inflammatory cytokines, and 4) Improve survival. Thus, probiotics could offer important benefits to HIV infected patients by improving intestinal function and reducing subsequent microbial translocation and immune activation. These benefits may vary by race.

OBJECTIVE. To determine the effect of an oral synbiotic supplement (Synbiotic 2000) on plasma LPS levels, systemic immune activation, and blood CD4 count in HIV infected women.

HYPOTHESIS. Oral treatment of HIV+ patients with this synbiotic supplement will improve intestinal barrier function, decrease the translocation of LPS into the circulation, and result in reduced systemic immune activation and improved CD4 count.

EXPERIMENTAL DESIGN. 30 HIV+ female subjects will be randomized to test supplement or placebo and undergo a baseline blood draw to establish initial values for plasma LPS, immune activation markers, and blood CD4 count. Following daily ingestion of the test supplement or placebo for 4 weeks, subjects will undergo a second blood draw for measurement of the same factors. Subjects will also provide a stool specimen at the beginning and end of the 4 week period.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
HIV Infection
  • Dietary Supplement: Synbiotic 2000
    A preparation consisting of 4 species of probiotic bacteria (10^10 each) combined with 4 types of dietary fiber (2.5g each).
    Other Name: Synbiotic 2000, Medipharm, Kagerod, Sweden
  • Dietary Supplement: Placebo
    Placebo
  • Experimental: Synbiotic
    Ingestion of synbiotic dietary supplement
    Intervention: Dietary Supplement: Synbiotic 2000
  • Placebo Comparator: Placebo
    Ingestion of the Placebo
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV seropositive
  • Adult Female
  • Currently taking antiretroviral medication

Exclusion Criteria:

  • AIDS-defining conditions
  • Current use of oral antibiotics
  • Inflammatory bowel disease or other known GI pathology
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00688311
200715524-1
No
J William Critchfield/Associate Project Scientist, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Bill Critchfield, Ph.D. University of California, Davis
University of California, Davis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP