Clinical Trials

MainTitle

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
Sponsor
Biocodex


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002088

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: March 1996
History of Changes
Purpose

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 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
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:

Enrollment: 100

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party: Biocodex  
ClinicalTrials.gov Identifier: NCT00002088   History of Changes  
Other Study ID Numbers: 083A  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Diarrhea
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Saccharomyces

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Diarrhea
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.