Addition of Lactobacillus to Metronidazole in Treatment of CDAD - Full Text View

Sponsors and Collaborators:	VA Medical Center, Houston Baylor College of Medicine
Information provided by:	VA Medical Center, Houston
ClinicalTrials.gov Identifier:	NCT00304863

Purpose

The purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.

Condition	Intervention	Phase
Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis	Drug: Lactobacillus GG	Phase IV

Drug Information available for: Metronidazole Metronidazole hydrochloride Metronidazole phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease

Further study details as provided by VA Medical Center, Houston:

Primary Outcome Measures:

Response to Treatment
Stool sample C. diff toxin assay

Estimated Enrollment:

70

Detailed Description:

Clostridium difficile associated disease (CDAD), which nearly always follows antibiotic therapy, has become increasingly common and important in American hospitals, causing substantial morbidity and mortality. Metronidazole is the recommended treatment for this condition. We have recently reported (Clin Infect Dis, June 2005) that treatment with metronidazole is associated with a 22% rate of failure and 28% rate of relapse. No other medication has been shown to be more effective. There is a substantial theory and some limited data to suggest that dietary supplementation with non-pathogenic normal bowel bacteria will benefit these patients. Lactobacillus GG is the best-standardized and the most extensively studied of these agents.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin

Exclusion Criteria:

Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded.
Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304863

Locations

United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

VA Medical Center, Houston

Baylor College of Medicine

Investigators

Principal Investigator:

Daniel M Musher, M.D.

Baylor College of Medicine, Houston VA Medical Center

More Information

Study ID Numbers:	H-17937
Study First Received:	March 16, 2006
Last Updated:	March 16, 2006
ClinicalTrials.gov Identifier:	NCT00304863
Health Authority:	United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:

CDAD
Clostridium difficile Associated Diarrhea

Study placed in the following topic categories:

Bacterial Infections
Metronidazole
Diarrhea
Gastrointestinal Diseases
Colonic Diseases
Enterocolitis, Pseudomembranous
Intestinal Diseases

Enterocolitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Gastroenteritis
Clostridium Infections
Colitis

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Radiation-Sensitizing Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009