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

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ClinicalTrials.gov Identifier: NCT01472978
Recruitment Status : Unknown
Verified June 2012 by Susan Baker, State University of New York at Buffalo.
Recruitment status was:  Recruiting
First Posted : November 17, 2011
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Susan Baker, State University of New York at Buffalo

Brief Summary:
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 or disease Intervention/treatment
C. Difficile Infection Drug: metronidazole

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy
Study Start Date : December 2011
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Cessation of GI symptoms: nausea, bloating, pain, constipation or diarrhea, vomiting, weight loss, [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): 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

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 ( Other Identifier: Women and Children's Hospital of Buffalo )
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents