Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy

Withdrawn before enrolling · Not applicable

Conditions studied: C. Difficile Infection

In brief

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.

Key facts

Study ID: NCT01472978
Run by: State University of New York at Buffalo
People needed: 0
Starts: 2011-12-01
Expected to finish: 2014-12-01
Last updated by the study team: 2019-07-25

Who can join

Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Women and Children's Hospital — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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