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 - 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.

Study Overview

• Status: Terminated
• Conditions: Chronic Diarrhea; Chronic Abdominal Pain
• Intervention / Treatment: Other: Fecal calprotectin level

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Queen's University
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston University Hospital Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fecal calprotectin level	Other: Fecal calprotectin level
NO_INTERVENTION: Symptom questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to final diagnosis	Up to 12 months from enrollment

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Angela Noble, MD, Queen's University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: May 27, 2013
• First Posted (ESTIMATE): May 31, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Diarrhea; Abdominal Pain
• Other Study ID Numbers: Q4415