NCT02984059

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

February 3, 2016

Last Update Submit

February 7, 2019

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Genetic: Genomic DNAGenetic: RNA analysisGenetic: MicrobiomeOther: CalprotectinOther: Pain questionnairesOther: Anxiety/Depression Questionnaires

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

Genetic: Genomic DNAGenetic: RNA analysisGenetic: MicrobiomeOther: CalprotectinOther: Pain questionnairesOther: Anxiety/Depression Questionnaires

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.

Genetic: Genomic DNAGenetic: RNA analysisGenetic: MicrobiomeOther: Calprotectin

Interventions

Genomic DNAGENETIC

blood draw

Colonoscopy other reasons no abd painIBD w/abdominal painIBD w/out abdominal pain
RNA analysisGENETIC

Mucosal Biopsy via colonoscopy

Colonoscopy other reasons no abd painIBD w/abdominal painIBD w/out abdominal pain
MicrobiomeGENETIC

Stool microbiome

Colonoscopy other reasons no abd painIBD w/abdominal painIBD w/out abdominal pain
CalprotectinOTHER

stool or blood analysis for calprotectin

Colonoscopy other reasons no abd painIBD w/abdominal painIBD w/out abdominal pain
Pain questionnairesOTHER

PSDS PCS-C/P PBI APPT

IBD w/abdominal painIBD w/out abdominal pain
Anxiety/Depression QuestionnairesOTHER

RCADS-25 CSI-24 ARCS

IBD w/abdominal painIBD w/out abdominal pain

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center

You may qualify if:

  • Age ≥ 8 years or \< 18 years (achieved 8th birthday but not yet their 18th birthday)
  • IBD established by standard criteria
  • Anticipated availability for follow up for ≥ 1 year
  • Informed consent/assent

You may not qualify if:

  • Prior abdominal surgery unrelated to IBD
  • Active gastrointestinal infection at time of diagnosis (e.g., C. difficile)
  • Other co-morbidities that contribute to abdominal pain (e.g., Familial Mediterranean Fever, metabolic disease)
  • Preexisting chronic pain disorder (e.g., fibromyalgia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CT Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

  • 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.

    PMID: 31627210DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

pending

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

DNA ProbesMicrobiotaLeukocyte L1 Antigen Complex

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid ProbesNucleic AcidsNucleic Acids, Nucleotides, and NucleosidesMolecular ProbesDiagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesLaboratory ChemicalsSpecialty Uses of ChemicalsMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public HealthS100 ProteinsCalcium-Binding ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsAntigens, SurfaceAntigensBiological Factors

Study Officials

  • Victoria Grossi, DO

    Connecticut Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Fellow/GI Department

Study Record Dates

First Submitted

February 3, 2016

First Posted

December 6, 2016

Study Start

October 21, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)