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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002088 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Efficacy Study

Condition ^ICMJE

Diarrhea
HIV Infections

Intervention ^ICMJE

Drug: Saccharomyces boulardii

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002088

Responsible Party

Study ID Numbers ^ICMJE

083A

Study Sponsor ^ICMJE

Biocodex

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Surawicz CM

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

March 1996

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP