NCT00002088

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

DiarrheaHIV Infections

Keywords

DiarrheaAcquired Immunodeficiency SyndromeAIDS-Related ComplexSaccharomyces

Interventions

Saccharomyces boulardiiDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madison Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 8201735BACKGROUND

MeSH Terms

Conditions

DiarrheaHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Surawicz CM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-03

Locations

US(1)