Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial
This study has been completed.
Sponsor:
Biocodex
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002088
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea HIV Infections |
Drug: Saccharomyces boulardii |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002088 History of Changes |
| Other Study ID Numbers: | 083A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex Saccharomyces |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Diarrhea Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013