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Addition of Lactobacillus to Metronidazole in Treatment of CDAD

This study has been withdrawn prior to enrollment.
(The assistant who was going to do this study moved to a different med center)
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston Identifier:
First received: March 16, 2006
Last updated: May 2, 2016
Last verified: May 2016
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
Pseudomembranous Colitis
Antibiotic-associated Colitis
Drug: Lactobacillus GG
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
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

Enrollment: 0
Arms Assigned Interventions
No Intervention: Arm 1
This are will not receive Lactobacillus
Experimental: Arm 2
This arm will receive lactobacillus
Drug: Lactobacillus GG
Probiotic lactobacillus GG

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00304863

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
Principal Investigator: Daniel M Musher, M.D. Baylor College of Medicine, Houston VA Medical Center
  More Information

Responsible Party: Daniel M. Musher MD, Principle Investigator, VA Medical Center, Houston Identifier: NCT00304863     History of Changes
Other Study ID Numbers: H-17937
Study First Received: March 16, 2006
Last Updated: May 2, 2016

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

Additional relevant MeSH terms:
Enterocolitis, Pseudomembranous
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on April 28, 2017