Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02984059
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015342', 'term': 'DNA Probes'}, {'id': 'D064307', 'term': 'Microbiota'}, {'id': 'D039841', 'term': 'Leukocyte L1 Antigen Complex'}], 'ancestors': [{'id': 'D015341', 'term': 'Nucleic Acid Probes'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015335', 'term': 'Molecular Probes'}, {'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D008827', 'term': 'Microbiological Phenomena'}, {'id': 'D058448', 'term': 'Biota'}, {'id': 'D044822', 'term': 'Biodiversity'}, {'id': 'D017753', 'term': 'Ecosystem'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D009418', 'term': 'S100 Proteins'}, {'id': 'D002135', 'term': 'Calcium-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'pending'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires', 'timeFrame': 'Assessed at baseline then at months 3, 6, 9, and 12', 'description': 'Changes in abdominal pain from baseline then assessed again at 3, 6, 9, and 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '31627210', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "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.\n\nThe study participants will be seen every 3 months for a year and they will have the following procedures/test performed:\n\n1. Standard of care blood and stool samples\n2. Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease Activity Index (PCDAI)\n\nThey will have an endoscopy performed at diagnosis then at 12 months from enrollment.\n\nA magnetic resonance enterography (MRE) will be done at diagnosis.\n\nThe following pain and anxiety tests will be performed throughout the study:\n\nPain:\n\nPain Severity Duration Scale (PSDS) Pediatric Catastrophizing Scale-Child/Parents (PCS-C/P) Pain Burden Interview (PBI) Adolescent Pediatric Pain Tool (APPT)\n\nAnxiety:\n\nRevised Children's Anxiety and Depression Scale (RCADS-25) Children's Somatization Index (CSI-24) Adult Responses to Children's Symptoms (ARCS)\n\nBlood, 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.\n\nIn summary, the investigators will be examining:\n\n1. Relationship between clinical factors and persistent abdominal pain in patients with IBD\n\n 1. Disease type\n 2. Location of disease at diagnosis\n 3. Extent of disease at diagnosis\n 4. Markers of inflammation at diagnosis and over the course of follow up\n 5. Active disease vs. inactive disease over the course of follow up\n2. Relationship between psychosocial factors persistent abdominal pain, and remission status, specifically in patients with:\n\n 1. Inactive IBD vs. active IBD\n 2. Inactive IBD vs. IBS/FAP\n 3. We will compare the parental report to patient report in the above mentioned groups\n3. Relationship between gene expression, microbiome, persistent abdominal pain, and remission status, specifically in patients with:\n\n 1. Inactive IBD vs. active IBD\n 2. Inactive IBD vs. IBS/FAP\n 3. Inactive IBD vs. controls with no abdominal pain"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 8 years or \\< 18 years (achieved 8th birthday but not yet their 18th birthday)\n* IBD established by standard criteria\n* Anticipated availability for follow up for ≥ 1 year\n* Informed consent/assent\n\nExclusion Criteria:\n\n* Prior abdominal surgery unrelated to IBD\n* Active gastrointestinal infection at time of diagnosis (e.g., C. difficile)\n* Other co-morbidities that contribute to abdominal pain (e.g., Familial Mediterranean Fever, metabolic disease)\n* Preexisting chronic pain disorder (e.g., fibromyalgia)'}, 'identificationModule': {'nctId': 'NCT02984059', 'briefTitle': 'Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': "Connecticut Children's Medical Center"}, 'officialTitle': 'A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study', 'orgStudyIdInfo': {'id': 'The ALLAY Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD w/abdominal pain', 'description': "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.\n\nPain questionnaires:\n\nPain 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", 'interventionNames': ['Genetic: Genomic DNA', 'Genetic: RNA analysis', 'Genetic: Microbiome', 'Other: Calprotectin', 'Other: Pain questionnaires', 'Other: Anxiety/Depression Questionnaires']}, {'label': 'IBD w/out abdominal pain', 'description': "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.\n\nPain questionnaires:\n\nPain 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", 'interventionNames': ['Genetic: Genomic DNA', 'Genetic: RNA analysis', 'Genetic: Microbiome', 'Other: Calprotectin', 'Other: Pain questionnaires', 'Other: Anxiety/Depression Questionnaires']}, {'label': 'Colonoscopy other reasons no abd pain', 'description': '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.', 'interventionNames': ['Genetic: Genomic DNA', 'Genetic: RNA analysis', 'Genetic: Microbiome', 'Other: Calprotectin']}], 'interventions': [{'name': 'Genomic DNA', 'type': 'GENETIC', 'description': 'blood draw', 'armGroupLabels': ['Colonoscopy other reasons no abd pain', 'IBD w/abdominal pain', 'IBD w/out abdominal pain']}, {'name': 'RNA analysis', 'type': 'GENETIC', 'description': 'Mucosal Biopsy via colonoscopy', 'armGroupLabels': ['Colonoscopy other reasons no abd pain', 'IBD w/abdominal pain', 'IBD w/out abdominal pain']}, {'name': 'Microbiome', 'type': 'GENETIC', 'description': 'Stool microbiome', 'armGroupLabels': ['Colonoscopy other reasons no abd pain', 'IBD w/abdominal pain', 'IBD w/out abdominal pain']}, {'name': 'Calprotectin', 'type': 'OTHER', 'description': 'stool or blood analysis for calprotectin', 'armGroupLabels': ['Colonoscopy other reasons no abd pain', 'IBD w/abdominal pain', 'IBD w/out abdominal pain']}, {'name': 'Pain questionnaires', 'type': 'OTHER', 'description': 'PSDS PCS-C/P PBI APPT', 'armGroupLabels': ['IBD w/abdominal pain', 'IBD w/out abdominal pain']}, {'name': 'Anxiety/Depression Questionnaires', 'type': 'OTHER', 'description': 'RCADS-25 CSI-24 ARCS', 'armGroupLabels': ['IBD w/abdominal pain', 'IBD w/out abdominal pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "CT Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Victoria Grossi, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Connecticut Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Connecticut Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Fellow/GI Department', 'investigatorFullName': 'Victoria Grossi', 'investigatorAffiliation': "Connecticut Children's Medical Center"}}}}