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


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Diarrhea

Dysentery


Clinical Trial: 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.

Sponsored by: Biocodex
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention Phase
Diarrhea
HIV Infections
 Drug: Saccharomyces boulardii
Phase II

MedlinePlus related topics:  AIDS;   Diarrhea

Study Type: Interventional
Study Design: Treatment, Double-Blind, Efficacy Study

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

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).

Location Information


Washington
      Madison Clinic, Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Surawicz CM,  Study Chair

More Information

Publications

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.

Study ID Numbers:  083A
Record last reviewed:  March 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002088
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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