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

Primary Purpose

Diarrhea, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Saccharomyces boulardii
Sponsored by
Biocodex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saccharomyces

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Madison Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Biocodex
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1. Study Identification

Unique Protocol Identification Number
NCT00002088
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Biocodex

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, HIV Infections
Keywords
Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saccharomyces

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Saccharomyces boulardii

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surawicz CM
Official's Role
Study Chair
Facility Information:
Facility Name
Madison Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8201735
Citation
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. Erratum In: JAMA 1994 Aug 17;272(7):518.
Results Reference
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Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

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