Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
NCT ID: NCT00002088
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Saccharomyces boulardii
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Biocodex
INDUSTRY
Principal Investigators
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Surawicz CM
Role: STUDY_CHAIR
Locations
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Madison Clinic
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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083A
Identifier Type: -
Identifier Source: org_study_id