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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 Hiv Infections Studies:
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2. Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy

3. Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea

4. A Randomized Trial of Tap Water Treatment in the Elderly

5. A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients with Acquired Immunodeficiency Related Diarrhea who were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

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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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