Addition of Lactobacillus to Metronidazole in Treatment of CDAD

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston
ClinicalTrials.gov Identifier:
NCT00304863
First received: March 16, 2006
Last updated: February 14, 2013
Last verified: February 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Addition of a Probiotic (Lactobacillus GG) to Metronidazole for the Treatment of Clostridium Difficile Associated Disease

Resource links provided by NLM:


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
Study Start Date: January 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Daniel M. Musher MD, Principle Investigator, VA Medical Center, Houston
ClinicalTrials.gov Identifier: NCT00304863     History of Changes
Other Study ID Numbers: H-17937
Study First Received: March 16, 2006
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
CDAD
Clostridium difficile Associated Diarrhea

Additional relevant MeSH terms:
Colitis
Enterocolitis
Enterocolitis, Pseudomembranous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014