Chronic Diarrhea Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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