Trial record 15 of 39 for:    " May 07, 2008":" June 06, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention
HIV Infection
Dietary Supplement: Synbiotic 2000
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Pilot Trial of a Synbiotic in HIV+ Patients

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Plasma Lipopolysaccharide [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immune Activation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synbiotic
Ingestion of synbiotic dietary supplement
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
Placebo Comparator: Placebo
Ingestion of the Placebo
Dietary Supplement: Placebo
Placebo

Detailed Description:

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.

  Eligibility

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

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
  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: NCT00688311

Locations
United States, California
CARES Clinic
Sacramento, California, United States, 95811
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Bill Critchfield, Ph.D. University of California, Davis
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J William Critchfield/Associate Project Scientist, University of California, Davis
ClinicalTrials.gov Identifier: NCT00688311     History of Changes
Other Study ID Numbers: 200715524-1
Study First Received: May 16, 2008
Last Updated: November 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
HIV
synbiotic
probiotic
immune activation
blood CD4 count
bacterial translocation
Human Immunodeficiency Virus

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 July 24, 2014