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Search / Trial NCT00002088

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

Diarrhea Acquired Immunodeficiency Syndrome Aids Related Complex Saccharomyces

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.

Locations

Seattle, Washington, United States

People applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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