CompletedNot Applicable

Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health

United Kingdom19,469 participantsStarted 2022-01-05

Plain-language summary

This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years diagnosed with Inflammatory Bowel Disease (IBD) and the impacts of mental health conditions in those diagnosed with IBD.

Who can participate

Age range

5 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 5 years and 25 years * Registration with a general practices (GP) contributing routinely collected electronic healthcare data to the Optimum Patient Care Research Database (OPCRD) for more than 6 months during the follow up period * A recorded diagnosis of IBD in the clinical record (cases) Exclusion Criteria: • None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stream 1: Percentage of Participants Who Developed Any Mental Health Condition

Timeframe: 5 years

Stream 1: Relative Risk of Any Mental Health Condition

Timeframe: Retrospective data assessed from 2010-2020, up to 10 years

Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)

Timeframe: 5 years of follow-up.

Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)

Timeframe: 5 years of follow-up.

Stream 2: Relative Risk of Low Mood (Emotional Function)

Timeframe: 5 years of follow-up.

Trial details

NCT IDNCT05206734

SponsorMomentum Data

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-31

Results submitted2025-01-29

View on ClinicalTrials.gov More Inflammatory Bowel Diseases trials

Plain-language summary

Who can participate

Age range

5 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Stream 1: Percentage of Participants Who Developed Any Mental Health Condition

Timeframe: 5 years

Stream 1: Relative Risk of Any Mental Health Condition

Timeframe: Retrospective data assessed from 2010-2020, up to 10 years

Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)

Timeframe: 5 years of follow-up.

Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)

Timeframe: 5 years of follow-up.

Stream 2: Relative Risk of Low Mood (Emotional Function)

Timeframe: 5 years of follow-up.