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Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT02984059
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Victoria Grossi, Connecticut Children's Medical Center

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.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease Genetic: Genomic DNA Genetic: RNA analysis Genetic: Microbiome Other: Calprotectin Other: Pain questionnaires Other: Anxiety/Depression Questionnaires

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

Group/Cohort Intervention/treatment
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 DNA
blood draw
Genetic: RNA analysis
Mucosal Biopsy via colonoscopy
Genetic: Microbiome
Stool microbiome
Other: Calprotectin
stool or blood analysis for calprotectin
Other: Pain questionnaires
PSDS PCS-C/P PBI APPT
Other: Anxiety/Depression Questionnaires
RCADS-25 CSI-24 ARCS
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 DNA
blood draw
Genetic: RNA analysis
Mucosal Biopsy via colonoscopy
Genetic: Microbiome
Stool microbiome
Other: Calprotectin
stool or blood analysis for calprotectin
Other: Pain questionnaires
PSDS PCS-C/P PBI APPT
Other: Anxiety/Depression Questionnaires
RCADS-25 CSI-24 ARCS
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 DNA
blood draw
Genetic: RNA analysis
Mucosal Biopsy via colonoscopy
Genetic: Microbiome
Stool microbiome
Other: Calprotectin
stool or blood analysis for calprotectin



Primary Outcome Measures :
  1. Changes in abdominal pain from baseline at 3, 6, 9, and 12 months will be assessed using questionnaires [ 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.


Biospecimen Retention:   Samples With DNA
pending


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984059


Contacts
Contact: Victoria Grossi, DO 860-545-8564 Vgrossi@connecticutchildrens.org
Contact: Krista Spada 860-837-6354 Kspada@connecticutchildrens.org

Locations
United States, Connecticut
CT Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Krista Spada    860-837-6354    Kspada@connecticutchildrens.org   
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: Victoria Grossi, DO Connecticut Children's Medical Center

Responsible Party: Victoria Grossi, Pediatric Fellow/GI Department, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT02984059     History of Changes
Other Study ID Numbers: The ALLAY Study
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Abdominal Pain
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive