An observational study in Inflammatory Bowel Disease, sponsored by Connecticut Children's Medical Center. Completed at 1 site in United States. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-02-08.
Sponsored by Connecticut Children's Medical Center · Observational
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.
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:
Relationship between clinical factors and persistent abdominal pain in patients with IBD
Relationship between psychosocial factors persistent abdominal pain, and remission status, specifically in patients with:
Relationship between gene expression, microbiome, persistent abdominal pain, and remission status, specifically in patients with:
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 126 is close to the median of 140 across 377 observational studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Connecticut Children's Medical Center is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center
Exclusion Criteria:
Patients with IBD with abdominal pain. Extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for both genomic DNA and calprotectin, and stool analyzed for microbiome. If no blood is drawn then a buccal swab done for the genomic DNA analysis and stool analyzed for calprotectin. Pain questionnaires: Pain Frequency-Severity-Duration Scale Pain Catastrophizing Scale-Child Version Pain Burden Interview Pediatric Quality of Life Inventory Adolescent Pediatric Pain Tool Anxiety/Depression Questionnaires Revised Children's Anxiety and Depression Scale Children's Somatization Inventory Adult Responses to Children's Symptoms
Genetic: Genomic DNA · Genetic: RNA analysis · Genetic: Microbiome · Other: Calprotectin · Other: Pain questionnaires · Other: Anxiety/Depression Questionnaires
Patients with IBD and no abdominal pain. Colonoscopy done for standard of care, extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for genomic DNA and calprotectin and stool analyzed for microbiome. If no blood is drawn then a buccal swab for the genomic DNA analysis and stool analyzed for calprotectin. Pain questionnaires: Pain Frequency-Severity-Duration Scale Pain Catastrophizing Scale-Child Version Pain Burden Interview Pediatric Quality of Life Inventory Adolescent Pediatric Pain Tool Anxiety/Depression Questionnaires Revised Children's Anxiety and Depression Scale Children's Somatization Inventory Adult Responses to Children's Symptoms
Genetic: Genomic DNA · Genetic: RNA analysis · Genetic: Microbiome · Other: Calprotectin · Other: Pain questionnaires · Other: Anxiety/Depression Questionnaires
Patients who have a colonoscopy for other reasons, rectal bleeding or polyp surveillance, no abdominal pain. Extra colonic biopsies for RNA analysis. If blood and stool samples are collected for standard of care:blood analyzed for genomic DNA and calprotectin and stool analyzed for microbiome. If no blood is drawn then a buccal swab for the genomic DNA analysis and stool analyzed for calprotectin.
Genetic: Genomic DNA · Genetic: RNA analysis · Genetic: Microbiome · Other: Calprotectin
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
Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires
Changes in abdominal pain from baseline then assessed again at 3, 6, 9, and 12 months.
Time frame: Assessed at baseline then at months 3, 6, 9, and 12
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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