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

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

MedlinePlus related topics:

AIDS Diarrhea

ChemIDplus related topics:

Saccharomyces boulardii

U.S. FDA Resources

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

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
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002088
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

Study placed in the following topic categories:

Virus Diseases

Signs and Symptoms

Sexually Transmitted Diseases, Viral

Diarrhea

Signs and Symptoms, Digestive

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 10, 2008

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