COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Pilot Trial of a Synbiotic in HIV+ Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688311
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : November 23, 2009
Information provided by:
University of California, Davis

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Dietary Supplement: Synbiotic 2000 Dietary Supplement: Placebo Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Pilot Trial of a Synbiotic in HIV+ Patients
Study Start Date : May 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Plasma Lipopolysaccharide [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Immune Activation [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688311

Layout table for location information
United States, California
CARES Clinic
Sacramento, California, United States, 95811
Sponsors and Collaborators
University of California, Davis
Layout table for investigator information
Principal Investigator: Bill Critchfield, Ph.D. University of California, Davis

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: J William Critchfield/Associate Project Scientist, University of California, Davis Identifier: NCT00688311    
Other Study ID Numbers: 200715524-1
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009
Keywords provided by University of California, Davis:
immune activation
blood CD4 count
bacterial translocation
Human Immunodeficiency Virus
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases