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Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy (c diff)

This study is currently recruiting participants.
Verified June 2012 by State University of New York at Buffalo
Sponsor:
Information provided by (Responsible Party):
Susan Baker, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01472978
First received: November 14, 2011
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

The investigators found that community acquired C. diff occurs in children undergoing a colonoscopy. When they were treated their symptoms got better. But, the investigators do not know if the treatment for the C. diff made them better or another other factor made them feel better. So, the investigators designed the following study. Children undergoing a colonoscopy who are found to be C. diff positive at the time of the colonoscopy are randomized to one group that gets immediate treatment or a second group that gets delayed treatment. Both groups are closely monitored for symptoms.


Condition Intervention
C. Difficile Infection
 Drug: metronidazole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Cessation of GI symptoms: nausea, bloating, pain, constipation or diarrhea, vomiting, weight loss, [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate antibiotic treatment
Patients will be treated with an antibiotic as soon as the aspirate obtained at the colonoscopy is found to be positive for C. diff.
 Drug: metronidazole
Metronidazole, 500 mg three times a for 10 days
Other Name: Flagyl
Sham Comparator: Delayed treatment with an antibiotic
Treatment will be started after a delay after the aspirate obtained at the colonoscopy is found to be C. diff positive.
 Drug: metronidazole
Metronidazole, 500 mg three times a for 10 days
Other Name: Flagyl

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aspirate at colonoscopy positive for C. diff.
  • Any gender
  • Any race
  • Age between 7-21
  • Greater than 21 kg
  • Able to swallow pills

Exclusion Criteria:

  • Abdominal tenderness and distention with minimal diarrhea
  • History of inflammatory bowel disease
  • Fever
  • Systemic toxicity or allergy to metronidazole
  • Short bowel syndrome
  • History of bowel resection vii
  • History of abdominal surgery (excluding appendectomy or cholecystectomy)
  • History of hirschsprungs disease x
  • Pregnant
  • Inability to participate in phone surveys
  • Inability to maintain scheduled clinic follow up

At time of Colonoscopy:

  • Visual evidence of pseudomembranes
  • Visible ulcerations
  • Mucosal friability iv.
  • Fissures/fistulas
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472978

Contacts
Contact: Susan S. Baker, MD, PhD 716-878-7793 sbaker@upa.chob.edu
Contact: Diana Moya, MD 716-878-7793 dmoya@upa.chob.edu

Locations
United States, New York
Women and Children's Hospital Recruiting
Buffalo, New York, United States, 14222
Contact: Zebunnissa Memon, MD     716-878-7793     zmemon@upa.chob.edu    
Principal Investigator: Susan S. Baker, MD, PhD            
Sub-Investigator: Diana Moya, MD            
Sub-Investigator: Zebunnissa Memon, MD            
Sponsors and Collaborators
State University of New York at Buffalo
  More Information

No publications provided

Responsible Party: Susan Baker, Professor of Pediatrics, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01472978     History of Changes
Other Study ID Numbers: C diff 101, WCHOB 101
Study First Received: November 14, 2011
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
C. difficile

Additional relevant MeSH terms:
Anti-Bacterial Agents
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013