NCT04995224

Brief Summary

Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD). Up to 70 % of IBD patients experience pain when the disease is active. Even when patients with IBD are in remission, 20-50 % experience ongoing pain. The precise mechanism of developing chronic abdominal pain in patients with IBD in remission remains unknown. The aim of this study is to identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed IBD (ulcerative colitis and Crohn's disease). This study consists of 4 sections (Study 1A, 1B, 2, and 3): Study 1A: We perform a longitudinal study in 150 patients with new-onset IBD over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain. This is a collaborative study with IBD BioResourse Inception study. We administer online questionnaires, collect stool and blood samples, and record heart rate. Other physiological data collected by the Inception study will be also used for the analysis. Study 1B: This is also a collaborative study with the Inception study. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients (n=450) that are included in the Inception study on a voluntary basis. Patients will be followed for 12 months. Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD. The participants for study 2 are patients registered in IBD BOOST study and those for study 3 are patients registered in IBD BioResource (but not in IBD Boost study). Detailed online questionnaires will be administered to them. These studies are just one-day assessment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 26, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

4.4 years

First QC Date

July 29, 2021

Last Update Submit

July 23, 2025

Conditions

Inflammatory Bowel Diseases

Keywords

inflammatory bowel diseases, IBD

Outcome Measures

Primary Outcomes (2)

  • Identification of psychophysiological and biological risk factors for development of chronic abdominal pain

    To identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed inflammatory bowel disease (ulcerative colitis and Crohn's disease) in a prospective longitudinal cohort study design

    3 years

  • Build predictive models for chronic pain using artificial intelligence and machine learning

    To use artificial intelligence (AI) and machine learning (ML) to build predictive models that use longitudinal data to identify patients who will develop chronic pain

    3 years

Secondary Outcomes (5)

  • Chronic abdominal pain prevalence

    3 years

  • Co-morbid pain in IBD remission

    3 years

  • Lifestyle factors and quality of life

    3 years

  • Environmental sensitivity

    3 years

  • Prevalence of IBS in IBD remission

    3 years

Study Arms (4)

Study 1A

Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease

Other: Assessment of Psychophysiological factorsBiological: Assessment of Biological factorsGenetic: Assessment of GeneticsBehavioral: Assessment of Quality of Life

Study 1B

Prospective cohort study with 450 newly diagnosed patients with IBD

Other: Assessment of Psychophysiological factorsGenetic: Assessment of GeneticsBehavioral: Assessment of Quality of LifeBiological: Assessment of Biological factors

Study 2

Cross-sectional study with 10,000 patients in IBD Boost study

Other: Assessment of Psychophysiological factorsGenetic: Assessment of GeneticsBehavioral: Assessment of Quality of Life

Study 3

Cross-sectional study with 15,000 patients in IBD BioResource

Other: Assessment of Psychophysiological factorsGenetic: Assessment of GeneticsBehavioral: Assessment of Quality of Life

Interventions

Assessment of Psychophysiological factorsOTHER

Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.

Study 1AStudy 1BStudy 2Study 3
Assessment of Biological factorsBIOLOGICAL

Investigating autonomic nervous function using heart rate recording, colon biopsy samples, microbiota, and blood cytokines levels. (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons. Blood samples and stool samples will be taken when participants come to the hospital for colonoscopy)

Study 1A
Assessment of GeneticsGENETIC

Genetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.

Study 1AStudy 1BStudy 2Study 3
Assessment of Quality of LifeBEHAVIORAL

Investigating QOL by questionnaires.

Study 1AStudy 1BStudy 2Study 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is males and females over the age of 18 who have been diagnosed with ulcerative colitis or Crohn's disease within the past 6 months before enrolment.

You may qualify if:

  • Males or females who are over 18 years old.
  • Patients who are diagnosed with UC or CD within 6 months before the enrolment.
  • Patients who have access to the internet and have the IT skills to perform basic tasks e.g. operate emails and fill out questionnaires.
  • Patients who are willing and able to participate in the study for the required duration, can understand and are willing to sign the consent forms and agree to undergo all protocol-related tests and procedures.

You may not qualify if:

  • Patients who have severe extensive colitis and are at imminent risk of colectomy.
  • Patients who already have the presence of a stoma or history of a fistula or stricture due to another diagnosis.
  • Patients who are pregnant, lactating or thinking of becoming pregnant during the study period
  • Patients who have unstable acute illness or exacerbation of an unstable chronic illness or chronic disease (other than IBD) that may affect assessments for this study as determined by previous physical examination, medical history, vital signs, ECG, and laboratory (serum biochemistry, hematology, urinalysis) assessments.
  • Patients with a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection that are not in remission and are on medication that can affect gastrointestinal function.
  • Patients who have known or suspected to have a severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF) and chronic arrhythmia such as atrial fibrillation
  • Patients who have known or suspected cerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
  • Patients who have a known history or suspected history of substance abuse or addiction (within the last five years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London

London, E1 2AJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, stool samples, and colon biopsies from a maximum of 150 patients in study 1A

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Qasim Aziz

    Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iman Khwaja

CONTACT

02078822655i.khwaja@qmul.ac.uk

Kazuya Takahashi

CONTACT

02078822655kazuya.takahashi@qmul.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 6, 2021

Study Start

July 26, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations

GB(1)