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
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
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.
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