Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy

NCT01472978 | Withdrawn

• 2 other identifiers: C diff 101WCHOB 101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

C. Difficile Infection

Keywords

C. difficile

Outcome Measures

Primary Outcomes (1)

• Cessation of GI symptoms: nausea, bloating, pain, constipation or diarrhea, vomiting, weight loss,

  2 weeks

Study Arms (2)

Immediate antibiotic treatment

ACTIVE COMPARATOR

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

Delayed treatment with an antibiotic

SHAM COMPARATOR

Treatment will be started after a delay after the aspirate obtained at the colonoscopy is found to be C. diff positive.

Drug: metronidazole

Interventions

metronidazole DRUG

Metronidazole, 500 mg three times a for 10 days

Also known as: Flagyl

Delayed treatment with an antibiotic; Immediate antibiotic treatment

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Women and Children's Hospital

Buffalo, New York, 14222, United States

Location

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 25, 2019

Record last verified: 2012-06

Locations

US (1)