Evaluation of Fecal Calprotectin Screening and a Gastroenterology Questionnaire for Triaging Children With Chronic Abdominal Pain and/or Diarrhea Referred to a Pediatric Gastroenterology Service

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT01866774
First received: January 3, 2013
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

Triaging new pediatric gastroenterology consultations is challenging as both inflammatory and non-inflammatory gastrointestinal (GI) diseases can present with non-specific chronic abdominal pain and/or diarrhea. Examples of inflammatory GI diseases include Crohn's disease, ulcerative colitis and celiac disease and non-inflammatory GI diseases lactose intolerance, irritable bowel syndrome and non-ulcer dyspepsia. Inflammatory GI diseases require different investigations and treatment than non-inflammatory GI diseases and ideally, would be identified early. Higher priority triage of these patients would allow timely organization of further investigations including pertinent laboratory testing, radiologic studies and gastrointestinal endoscopies. These more invasive procedures are not needed in most patients presenting with non-specific gastrointestinal symptoms. Therefore, the investigators do not routinely ask for screening laboratory testing or other studies in children referred to our clinic.

Non-invasive screening tests for GI disorders may aid in appropriately triaging new consultations to pediatric gastroenterology. Calprotectin is a protein found in inflammatory cells called neutrophils. The concentration of calprotectin in stool reflects the presence of an inflammatory process occurring in the GI tract. Thus, testing for calprotectin has been proposed as a potentially useful test for detecting some inflammatory GI diseases, most notably Crohn's disease and ulcerative colitis. Alternatively, a simple gastrointestinal questionnaire of "red flag" symptoms and family history of GI disorders may also be of benefit. The investigators hypothesize that the use of fecal calprotectin and a screening GI questionnaire will aid in identifying children at higher risk of an inflammatory GI disorder. Subsequently, higher priority triaging of these patients will decrease the time to diagnosis of inflammatory GI disease.

This will be a single centre, stratified, randomized clinical trial conducted in Kingston, Ontario, Canada. Patients referred to the pediatric gastroenterology service without a known diagnosis for non-specific chronic abdominal pain and/or diarrhea will be asked to participate in the study. All patients who meet the inclusion criteria will be consented by telephone with a standard form. Consenting patients will be mailed the GI questionnaire and the fecal calprotectin test kit. The fecal calprotectin test kid includes instructions, a stool collection kit and return postage. All patients will be given the next available appointment with a pediatric gastroenterologist. Patients will then be randomized to receive either usual care (50%, 40 patients) or to have a screening fecal calprotectin (FC) measurement (50%, 40 patients). Patients in the FC group will have FC measured by the Quantum Blue® Rapid Calprotectin Assay. If the calprotectin level is high (above 50 μg/g), the patient will be contacted again by telephone and given a new appointment time (within 14 working days). This study may have a positive impact by demonstrating a novel method for decreasing the time to diagnosis of inflammatory GI disease.


Condition Intervention
Chronic Abdominal Pain
Chronic Diarrhea
Other: Fecal calprotectin level

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Fecal Calprotectin Screening and a Gastroenterology Questionnaire for Triaging Children With Chronic Abdominal Pain and/or Diarrhea Referred to a Pediatric Gastroenterology Service - A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Time to final diagnosis [ Time Frame: Up to 12 months from enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal calprotectin level
Fecal calprotectin level
Other: Fecal calprotectin level
No Intervention: Symptom questionnaire

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • have been referred to the pediatric gastroenterology service at the Kingston University Hospital Network for abdominal pain or chronic diarrhea
  • be between 5 to 17 years of age

Exclusion criteria:

  • overt signs and symptoms of an inflammatory gastrointestinal disease in the referral letter (will triaged with high priority within 14 working days
  • evidence of GI bleeding, extraintestinal manifestations of inflammatory bowel disease, significant weight loss or laboratory abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866774

Contacts
Contact: Angela J Noble, MD 613-549-6666 ext 6375

Locations
Canada, Ontario
Queen's University Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Angela J Noble, MD    613-549-6666 ext 6375      
Principal Investigator: Angela J Noble, MD         
Kingston University Hospital Network Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Noble    613-549-6666 ext 6375      
Principal Investigator: Angela J Noble, MD         
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Angela Noble, MD Kingston General Hospital
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT01866774     History of Changes
Other Study ID Numbers: Q4415
Study First Received: January 3, 2013
Last Updated: May 27, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diarrhea
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on September 18, 2014