Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
Launched by BIOCODEX · Aug 30, 2001
Trial Information
Current as of March 19, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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).
Trial Officials
Surawicz CM
Study Chair
About Biocodex
Biocodex is a global biopharmaceutical company dedicated to improving patient health through innovative therapies and high-quality healthcare solutions. With a strong focus on gut health, neurology, and critical care, Biocodex invests in research and development to advance its portfolio of products, including prescription medications and over-the-counter remedies. Committed to scientific excellence and ethical standards, Biocodex collaborates with healthcare professionals and stakeholders to enhance patient outcomes and foster a healthier future. Its robust clinical trial activities demonstrate a dedication to evidence-based medicine and continuous improvement in therapeutic practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seattle, Washington, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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