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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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002088
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002088 on ClinicalTrials.gov Archive Site
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Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial

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.

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Interventional
Phase 2
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Diarrhea
  • HIV Infections
Drug: Saccharomyces boulardii
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002088
083A
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Biocodex
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Study Chair: Surawicz CM
NIH AIDS Clinical Trials Information Service
March 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP