Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Biocodex
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002088

Purpose

To assess the efficacy of Saccharomyces boulardii (a nonpathogenic yeast) in producing a significant reduction in diarrheal symptoms in HIV-infected patients with chronic diarrhea.

Condition	Intervention	Phase
Diarrhea HIV Infections	Drug: Saccharomyces boulardii	Phase II

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Efficacy Study
Official Title:	Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

Resource links provided by NLM:

MedlinePlus related topics: AIDS Diarrhea

Drug Information available for: Saccharomyces boulardii

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

100

Eligibility

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Antiviral medication for HIV infection.

Patients must have:

Documented HIV infection.
Chronic diarrhea (for at least 1 month) that is either a manifestation or complication of documented HIV infection.
Had a stool culture (Salmonella, Shigella, Campylobacter, and Clostridium difficile) and stool analysis for ova and parasite (O/P X 3) within the past 2 months.
Failed antimicrobial treatment for diarrhea OR received no prior antimicrobials for stool pathogens because stool cultures were negative.

Patients who are on antiviral medications for HIV infection must have received such medication for at least 2 weeks and must remain on stable dose for weeks 1 and 2 of study.

Prior Medication:

Allowed:

Prior antiviral medication for HIV infection (if on such medication, must have received it for at least 2 weeks).
Standard antimicrobial therapy for a documented positive gastrointestinal pathogen.

Exclusion Criteria

Concurrent Medication:

Excluded:

Gastrointestinal medications that cause diarrhea (e.g., magnesium-containing antacids, lactulose).
Maintenance antifungal medication for life-threatening fungal infections (other than fluconazole <= 100 mg/day).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002088

Locations

United States, Washington
Madison Clinic
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Biocodex

Investigators

Study Chair:

Surawicz CM

More Information

Publications:

McFarland LV, Surawicz CM, Greenberg RN, Fekety R, Elmer GW, Moyer KA, Melcher SA, Bowen KE, Cox JL, Noorani Z, et al. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA. 1994 Jun 22-29;271(24):1913-8.

Study ID Numbers:	083A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002088 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Diarrhea
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Saccharomyces

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Diarrhea
Slow Virus Diseases
Signs and Symptoms, Digestive
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
Signs and Symptoms
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009