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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

For Condition: Diarrhea,HIV Infections
Status: Completed
Sponsor(s): Biocodex ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 100

Location and Contact Information:

Overall Study Official:
SurawiczCM,  Study Chair, 

Madison Clinic
Seattle,  Washington,  98104
United States
 


Additional Information:
Study ID Numbers:
  083A; 
Study Start Date: 
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002088

Other Diarrhea Studies:
1. A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

2. Testosterone for HIV-Positive Men with Reduced Serum Testosterone Levels and Abdominal Fat

3. A Study of Ro 24-7429 in Patients with HIV-Related Kaposi's Sarcoma

4. Safety and Effectiveness of Giving L-743,872 to Patients with Thrush That Has Not Been Cured With Fluconazole

5. Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients with Both HBV and HIV

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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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