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

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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.
Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

Treatment, Double-Blind, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Diarrhea
HIV Infections

Intervention ^†

Drug: Saccharomyces boulardii

MEDLINE PMIDs

8201735

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

100

Start Date ^†

Completion Date

Eligibility 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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00002088

Organization ID

083A

Secondary IDs ^††

Study Sponsor ^†

Biocodex

Collaborators ^††

Investigators ^†

Study Chair:

Surawicz CM

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

March 1996

First Received Date ^†

November 2, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.