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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002088
Enrollment
100
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, HIV Infections

Keywords

Diarrhea, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saccharomyces

Brief summary

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.

Interventions

Sponsors

Biocodex
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026