CT Children's Medical Center
Hartford, Connecticut, 06106, United States
NCT Number: NCT02984059
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.
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Notify Me8 year–18 year
All sexes
Observational
Hartford, Connecticut, 06106, United States
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Assessed at baseline then at months 3, 6, 9, and 12
Changes in abdominal pain from baseline then assessed again at 3, 6, 9, and 12 months.
Connecticut Children's Medical Center
Other
A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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