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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002088
• Other study ID #: 083A
• 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
• 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

• Acquired Immunodeficiency Syndrome
• Diarrhea
• HIV Infections
• Immunologic Deficiency Syndromes

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