Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
Completed · Phase 2
Conditions studied: Diarrhea, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002088
- Run by
- Biocodex
- People needed
- 100
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Madison Clinic — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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