Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Metronidazole

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