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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002088
Other study ID # 083A
Secondary ID
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date March 1996
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Saccharomyces boulardii


Locations

Country Name City State
United States Madison Clinic Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Biocodex

Country where clinical trial is conducted

United States, 

References & Publications (1)

McFarland LV, Surawicz CM, Greenberg RN, Fekety R, Elmer GW, Moyer KA, Melcher SA, Bowen KE, Cox JL, Noorani Z, et al. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA. 1994 Jun 22-29;271(24):1913-8. Erratum in: JAMA 1994 Aug 17;272(7):518. — View Citation

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