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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD w/abdominal pain | 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 |
| |
| IBD w/out abdominal pain | 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 |
| |
| Colonoscopy other reasons no abd pain | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genomic DNA | Genetic | blood draw |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at baseline then at months 3, 6, 9, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Grossi, DO | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CT Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31627210 | Derived | Grossi V, Hyams JS, Glidden NC, Knight BE, Young EE. Characterizing Clinical Features and Creating a Gene Expression Profile Associated With Pain Burden in Children With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Jul 17;26(8):1283-1290. doi: 10.1093/ibd/izz240. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015342 | DNA Probes |
| D064307 | Microbiota |
| D039841 | Leukocyte L1 Antigen Complex |
| ID | Term |
|---|---|
| D015341 | Nucleic Acid Probes |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015335 | Molecular Probes |
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pending
|
| RNA analysis | Genetic | Mucosal Biopsy via colonoscopy |
|
| Microbiome | Genetic | Stool microbiome |
|
| Calprotectin | Other | stool or blood analysis for calprotectin |
|
| Pain questionnaires | Other | PSDS PCS-C/P PBI APPT |
|
| Anxiety/Depression Questionnaires | Other | RCADS-25 CSI-24 ARCS |
|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D009418 | S100 Proteins |
| D002135 | Calcium-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |