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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304863
First Posted: March 20, 2006
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston
  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
Intervention Model: Single Group Assignment
Masking: Single (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 Daniel M. Musher MD, VA Medical Center, Houston:

Primary Outcome Measures:
  • Response to Treatment [ Time Frame: less than 10 days ]
    the time to resolution of diarrhea caused by diarrhea

  • Stool sample C. diff toxin assay [ Time Frame: 30 days after start of medication ]
    presence of C. diff toxin in stool after 30 days


Enrollment: 0
Anticipated Study Start Date: August 1, 2008
Estimated Study Completion Date: July 31, 2010
Estimated Primary Completion Date: July 31, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
This are will not receive Lactobacillus
Experimental: Arm 2
This arm will receive lactobacillus
Drug: Lactobacillus GG
This arm will receive the additional probiotic of lactobacillus GG
Other Name: Lactobacillus

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 16, 2006
First Posted: March 20, 2006
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Daniel M. Musher MD, 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
Antiprotozoal Agents
Antiparasitic Agents