Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Abdominal Pain
Study type: Observational

Summary: 
      To characterize persistent abdominal pain in children with inflammatory bowel disease (IBD)
      by examining factors such as disease type, activity and location, psychosocial factors, and
      genetics.

      The investigators hypothesize that by using patient pain and psychological assessments in
      addition to analysis of blood, stool and colonic biopsies, we can better characterize factors
      that predispose children and adolescents with IBD to have persistent and/or disproportionate
      abdominal pain.
    

Detailed description: 
      This is a prospective longitudinal inception cohort pilot study. The study will hopefully
      provide information about why there is persistent abdominal pain in children with IBD by
      examining factors such as disease type, activity and location, psychosocial factors, and
      genetics. Fifty newly diagnosed pediatric IBD patients, age 8-17 years will be enrolled into
      the study. There will be 2 control groups as well: pain control population: 20 patients with
      irritable bowel syndrome (IBS) or functional abdominal pain (FAP) diagnosis who have no
      evidence of bowel inflammation will serve as a pain control population for patients with no
      active inflammation. To serve as a control population for patients with no abdominal pain or
      inflammation, the investigators will include 10 patients with no gastrointestinal symptoms,
      who undergo colonoscopy for various reasons such as painless rectal bleeding, polyp
      surveillance, etc. The investigators anticipate completing enrollment in 12 months and
      allowed another 12 months for follow-up.

      The study participants will be seen every 3 months for a year and they will have the
      following procedures/test performed:

        1. Standard of care blood and stool samples

        2. Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease
           Activity Index (PCDAI)

      They will have an endoscopy performed at diagnosis then at 12 months from enrollment.

      A magnetic resonance enterography (MRE) will be done at diagnosis.

      The following pain and anxiety tests will be performed throughout the study:

      Pain:

      Pain Severity Duration Scale (PSDS) Pediatric Catastrophizing Scale-Child/Parents (PCS-C/P)
      Pain Burden Interview (PBI) Adolescent Pediatric Pain Tool (APPT)

      Anxiety:

      Revised Children's Anxiety and Depression Scale (RCADS-25) Children's Somatization Index
      (CSI-24) Adult Responses to Children's Symptoms (ARCS)

      Blood, rectal biopsies and stool specimens will be obtained throughout various time points of
      the study to look at hematology, sed rates, C-reactive protein, genomic DNA, colon RNA, stool
      microbiome and stool calprotectin.

      In summary, the investigators will be examining:

        1. Relationship between clinical factors and persistent abdominal pain in patients with IBD

             1. Disease type

             2. Location of disease at diagnosis

             3. Extent of disease at diagnosis

             4. Markers of inflammation at diagnosis and over the course of follow up

             5. Active disease vs. inactive disease over the course of follow up

        2. Relationship between psychosocial factors persistent abdominal pain, and remission
           status, specifically in patients with:

             1. Inactive IBD vs. active IBD

             2. Inactive IBD vs. IBS/FAP

             3. We will compare the parental report to patient report in the above mentioned groups

        3. Relationship between gene expression, microbiome, persistent abdominal pain, and
           remission status, specifically in patients with:

             1. Inactive IBD vs. active IBD

             2. Inactive IBD vs. IBS/FAP

             3. Inactive IBD vs. controls with no abdominal pain
    

Intervention name(s): Genomic DNA; RNA analysis; Microbiome; Calprotectin; Pain questionnaires; Anxiety/Depression Questionnaires
Intervention type(s): Genetic; Genetic; Genetic; Other; Other; Other
Intervention description(s): blood draw; Mucosal Biopsy via colonoscopy; Stool microbiome; stool or blood analysis for calprotectin; PSDS PCS-C/P PBI APPT; RCADS-25 CSI-24 ARCS
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study participants will be recruited from the GI clinic here at Connecticut Children's
        Medical Center
      
Biospecimen description: 
      pending