Expired Study
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Seattle, Washington 98104


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.


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).


Study is Available At:


Original ID:

083A


NCT ID:

NCT00002088


Secondary ID:


Study Acronym:


Brief Title:

Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial


Official Title:

Treatment of Patients With Human Immunodeficiency Virus (HIV)-Related Chronic Diarrhea With Saccharomyces Boulardii or Placebo: A Double Blind Trial


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:


Overall Contact Information

Official Name:Surawicz CM
Study Chair

Study Dates

Verification Date:March 1996
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Saccharomyces boulardii

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Biocodex

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:8201735

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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