Inflammatory Bowel DiseaseNCT02984059
Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Genomic DNA, RNA analysis and Microbiome
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2015to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
CT Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study
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.
Read the detailed description
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:
- Standard of care blood and stool samples
- Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease Activity Index (PCDAI)
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
- Disease type
- Location of disease at diagnosis
- Extent of disease at diagnosis
- Markers of inflammation at diagnosis and over the course of follow up
- Active disease vs. inactive disease over the course of follow up
- Relationship between psychosocial factors persistent abdominal pain, and remission status, specifically in patients with:
- Inactive IBD vs. active IBD
- Inactive IBD vs. IBS/FAP
- We will compare the parental report to patient report in the above mentioned groups
- Relationship between gene expression, microbiome, persistent abdominal pain, and remission status, specifically in patients with:
- Inactive IBD vs. active IBD
- Inactive IBD vs. IBS/FAP
- Inactive IBD vs. controls with no abdominal pain
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Genomic DNA, RNA analysis, Microbiome, Calprotectin, Pain questionnaires
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic DNAGenetic
blood draw
RNA analysisGenetic
Mucosal Biopsy via colonoscopy
MicrobiomeGenetic
Stool microbiome
CalprotectinOther
stool or blood analysis for calprotectin
Pain questionnairesOther
PSDS PCS-C/P PBI APPT
Anxiety/Depression QuestionnairesOther
RCADS-25 CSI-24 ARCS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Genomic DNA; Genetic: RNA analysis; Genetic: Microbiome; Other: Calprotectin; Other: Pain questionnaires; Other: 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 Receives: Genetic: Genomic DNA; Genetic: RNA analysis; Genetic: Microbiome; Other: Calprotectin; Other: Pain questionnaires; Other: 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. Receives: Genetic: Genomic DNA; Genetic: RNA analysis; Genetic: Microbiome; Other: Calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline then at months 3, 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start21 Oct 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Grossi, Connecticut Children's Medical Center
- Investigators
- Victoria Grossi, DO, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984059
- Sponsor's protocol ID
- The ALLAY Study
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31627210
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Risk Factors for Abdominal Pain in Children With Inflammatory Bowel Disease: The ALLAY Study
- ClinicalTrials.gov ID
- NCT02984059
- Acronym / sponsor ID
- The ALLAY Study
- Conditions
- Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Standard of care blood and stool samples
- Pediatric Ulcerative Colitis Activity Index (PUCAI) or Pediatric Crohn's Disease Activity Index (PCDAI)
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
- Disease type
- Location of disease at diagnosis
- Extent of disease at diagnosis
- Markers of inflammation at diagnosis and over the course of follow up
- Active disease vs. inactive disease over the course of follow up
- Relationship between psychosocial factors persistent abdominal pain, and remission status, specifically in patients with:
- Inactive IBD vs. active IBD
- Inactive IBD vs. IBS/FAP
- We will compare the parental report to patient report in the above mentioned groups
- Relationship between gene expression, microbiome, persistent abdominal pain, and remission status, specifically in patients with:
- Inactive IBD vs. active IBD
- Inactive IBD vs. IBS/FAP
- Inactive IBD vs. controls with no abdominal pain
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD w/abdominal pain | – | Genetic: Genomic DNA, Genetic: RNA analysis, Genetic: Microbiome, Other: Calprotectin, Other: Pain questionnaires, Other: Anxiety/Depression QuestionnairesPatients 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 | – | Genetic: Genomic DNA, Genetic: RNA analysis, Genetic: Microbiome, Other: Calprotectin, Other: Pain questionnaires, Other: Anxiety/Depression QuestionnairesPatients 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 | – | Genetic: Genomic DNA, Genetic: RNA analysis, Genetic: Microbiome, Other: CalprotectinPatients 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study participants will be recruited from the GI clinic here at Connecticut Children's Medical Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genomic DNAblood draw | Genetic | Colonoscopy other reasons no abd pain, IBD w/abdominal pain, IBD w/out abdominal pain |
| RNA analysisMucosal Biopsy via colonoscopy | Genetic | Colonoscopy other reasons no abd pain, IBD w/abdominal pain, IBD w/out abdominal pain |
| MicrobiomeStool microbiome | Genetic | Colonoscopy other reasons no abd pain, IBD w/abdominal pain, IBD w/out abdominal pain |
| Calprotectinstool or blood analysis for calprotectin | Other | Colonoscopy other reasons no abd pain, IBD w/abdominal pain, IBD w/out abdominal pain |
| Pain questionnairesPSDS PCS-C/P PBI APPT | Other | IBD w/abdominal pain, IBD w/out abdominal pain |
| Anxiety/Depression QuestionnairesRCADS-25 CSI-24 ARCS | Other | IBD w/abdominal pain, IBD w/out abdominal pain |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 31627210Grossi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Grossi, DO principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.