NCT00688311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

Enrollment Period

1.5 years

First QC Date

May 16, 2008

Last Update Submit

November 19, 2009

Conditions

HIV Infection

Keywords

HIVsynbioticprobioticimmune activationblood CD4 countbacterial translocationHuman Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • Plasma Lipopolysaccharide

    4 weeks

Secondary Outcomes (1)

  • Immune Activation

    4 weeks

Study Arms (2)

Synbiotic

EXPERIMENTAL

Ingestion of synbiotic dietary supplement

Dietary Supplement: Synbiotic 2000

Placebo

PLACEBO COMPARATOR

Ingestion of the Placebo

Dietary Supplement: Placebo

Interventions

Synbiotic 2000DIETARY_SUPPLEMENT

A preparation consisting of 4 species of probiotic bacteria (10\^10 each) combined with 4 types of dietary fiber (2.5g each).

Also known as: Synbiotic 2000, Medipharm, Kagerod, Sweden
Synbiotic
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV seropositive
  • Adult Female
  • Currently taking antiretroviral medication

You may not qualify if:

  • AIDS-defining conditions
  • Current use of oral antibiotics
  • Inflammatory bowel disease or other known GI pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CARES Clinic

Sacramento, California, 95811, United States

Location

Related Publications (5)

  • Brenchley JM, Price DA, Schacker TW, Asher TE, Silvestri G, Rao S, Kazzaz Z, Bornstein E, Lambotte O, Altmann D, Blazar BR, Rodriguez B, Teixeira-Johnson L, Landay A, Martin JN, Hecht FM, Picker LJ, Lederman MM, Deeks SG, Douek DC. Microbial translocation is a cause of systemic immune activation in chronic HIV infection. Nat Med. 2006 Dec;12(12):1365-71. doi: 10.1038/nm1511. Epub 2006 Nov 19.

    PMID: 17115046BACKGROUND

  • Rayes N, Seehofer D, Theruvath T, Schiller RA, Langrehr JM, Jonas S, Bengmark S, Neuhaus P. Supply of pre- and probiotics reduces bacterial infection rates after liver transplantation--a randomized, double-blind trial. Am J Transplant. 2005 Jan;5(1):125-30. doi: 10.1111/j.1600-6143.2004.00649.x.

    PMID: 15636620BACKGROUND

  • Kotzampassi K, Giamarellos-Bourboulis EJ, Voudouris A, Kazamias P, Eleftheriadis E. Benefits of a synbiotic formula (Synbiotic 2000Forte) in critically Ill trauma patients: early results of a randomized controlled trial. World J Surg. 2006 Oct;30(10):1848-55. doi: 10.1007/s00268-005-0653-1.

    PMID: 16983476BACKGROUND

  • Rayes N, Seehofer D, Theruvath T, Mogl M, Langrehr JM, Nussler NC, Bengmark S, Neuhaus P. Effect of enteral nutrition and synbiotics on bacterial infection rates after pylorus-preserving pancreatoduodenectomy: a randomized, double-blind trial. Ann Surg. 2007 Jul;246(1):36-41. doi: 10.1097/01.sla.0000259442.78947.19.

    PMID: 17592288BACKGROUND

  • Schunter M, Chu H, Hayes TL, McConnell D, Crawford SS, Luciw PA, Bengmark S, Asmuth DM, Brown J, Bevins CL, Shacklett BL, Critchfield JW. Randomized pilot trial of a synbiotic dietary supplement in chronic HIV-1 infection. BMC Complement Altern Med. 2012 Jun 29;12:84. doi: 10.1186/1472-6882-12-84.

    PMID: 22747752DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Bill Critchfield, Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2008

First Posted

June 2, 2008

Study Start

May 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations

US(1)