Inflammatory Bowel DiseasesNCT04995224
Mechanism of Chronic Pain in Patients With IBD
An observational study of Inflammatory Bowel Diseases, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Assessment of Psychophysiological factors, Assessment of Biological factors and Assessment of Genetics
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25,600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2021to 30 Sep 2027
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
London, E1 2AJ
Qasim Aziz, 02078822630, q.aziz@qmul.ac.uk
Qasim Aziz
About this study
Official title: Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease
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).
Read more
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.
Read the detailed description
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 (UC and CD) over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain.
First assessment period: On the first day of the study, we will have a video chat with the participant using one of the telecommunications applications (e.g. skype, zoom, Microsoft team, etc.) and obtain an electric consent form using DocuSign (https://www.docusign.co.uk/). Then, participants will be trained on how to use online validated questionnaires to evaluate their disease activity, symptoms and psychological state, presence or absence of irritable bowel syndrome (IBS), or pain elsewhere. Then, they will be asked to download a mobile phone camera heart rate variability app and be trained to use it. They will also be trained to use the experience sampling method (ESM) to profile gut symptoms and lifestyle via a smartphone app at 10 random times in a day.
After training, participants will fill out baseline online questionnaires using REDCap. Participants will also start answering questionnaires by ESM for 7 days and recording their heart rate (5 minutes) using the app once a day in the morning for 7 days.
2nd-4th assessment periods: Further assessment periods will be scheduled every 6 months. One-two days before each study period begins, we will remind the participants by email or phone call. On day 1, participants fill out the same online questionnaires (except personality, which is a stable trait) followed by 7 days ESM profiling as during their first assessment period. They will also be asked to record heart rate (5 minutes) once a day in the morning for 7days. Each patient will be followed at least 18 months until the 4th assessment period ends.
If patients agree, we will add online questionnaires to patients beyond the life of the grant (at 24 months and 36 months) when they are followed by the IBD BioResource inception study. (ESM and sample collection are not performed after 18 months follow)
This is a collaborative study with the IBD BioResource Inception study. The participants in our study will be asked to participate in the IBD BioResource Inception study as well. Biological data obtained by the BioResource Inception study, which will be used for the analysis.
Study 1B: This is also a collaborative study with the Inception study. Data for 600 patients will still need to be collected by the Inception study when our study starts. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients that are included in the Inception study on a voluntary basis. This will allow us to capture data on almost 600 patients (150 of these will be from study 1A).
Using both our 150 studied patients from study1A and 450 patients in the Inception cohort (study 1B), we will then use cutting edge techniques in machine learning to ascertain if artificial intelligence (AI) can predict individuals who will develop chronic abdominal pain.
Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD (both CD and UC patients). The participants for study 2 are patients who are registered in IBD BOOST study and those for study 3 are patients who are registered in IBD BioResource (but not in IBD Boost study).
The aims are to determine the prevalence of chronic pain in Crohn's and UC patients, the prevalence of comorbid pain and IBS, lifestyle factors, and quality of life. IBD BOOST questionnaire is due to be administered to 10,000 patients. We will invite these patients to complete additional questionnaires not covered by IBD BOOST. We also approach 15,000 patients from IBD BioResourse who are not included in the IBD Boost study and administer questionnaires to them. We will be able to identify risk factors and aid a predictive model from static time point data if a number of those individuals have pain and a number do not. Further, in study 2 and 3, we will be able to determine whether the risk factors identified in study 1A and 1B accurately identify patients with and without chronic pain.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Assessment of Psychophysiological factors, Assessment of Biological factors, Assessment of Genetics, Assessment of Quality of Life
- Keywords
- inflammatory bowel diseases, IBD
- 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.
Assessment of Psychophysiological factorsOther
Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.
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)
Assessment of GeneticsGenetic
Genetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.
Assessment of Quality of LifeBehavioural
Investigating QOL by questionnaires.
Assessment of Biological factorsBiological
Investigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).
| Study group | Role | What they receive |
|---|---|---|
| Study 1A | Prospective cohort study with 150 newly diagnosed patients with inflammatory bowel disease Receives: Other: Assessment of Psychophysiological factors; Biological: Assessment of Biological factors; Genetic: Assessment of Genetics; Behavioral: Assessment of Quality of Life | |
| Study 1B | Prospective cohort study with 450 newly diagnosed patients with IBD Receives: Other: Assessment of Psychophysiological factors; Genetic: Assessment of Genetics; Behavioral: Assessment of Quality of Life; Biological: Assessment of Biological factors | |
| Study 2 | Cross-sectional study with 10,000 patients in IBD Boost study Receives: Other: Assessment of Psychophysiological factors; Genetic: Assessment of Genetics; Behavioral: Assessment of Quality of Life | |
| Study 3 | Cross-sectional study with 15,000 patients in IBD BioResource Receives: Other: Assessment of Psychophysiological factors; Genetic: Assessment of Genetics; Behavioral: Assessment of Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 years
Secondary outcomes (5)
Chronic abdominal pain prevalence
To determine the prevalence of chronic abdominal pain
Measured: 3 years
Co-morbid pain in IBD remission
To determine the prevalence of co-morbid pain in patients with IBD in remission
Measured: 3 years
Lifestyle factors and quality of life
To study fatigue, lifestyle factors (e.g. sleep quality and dietary habits) and quality of life
Measured: 3 years
Environmental sensitivity
To study environmental sensitivity in patients with IBD
Measured: 3 years
Prevalence of IBS in IBD remission
To identify the prevalence of IBS in patients with IBD in remission
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start26 Jul 2021
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 25,600 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Cambridge, Barking, Havering and Redbridge University Hospitals NHS Trust, Barts & The London NHS Trust, University College London Hospitals, Royal Free Hospital NHS Foundation Trust, King's College London
- Responsible party
- Sponsor
- Investigators
- Qasim Aziz, Principal investigator, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995224
- Sponsor's protocol ID
- 279414
- Status last verified
- May 2026
- First submitted
- 29 Jul 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04995224
- Acronym / sponsor ID
- 279414
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- inflammatory bowel diseases, IBD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,600 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Cambridge, Barking, Havering and Redbridge University Hospitals NHS Trust, Barts & The London NHS Trust, University College London Hospitals, Royal Free Hospital NHS Foundation Trust, King's College London
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Aug 2021 (actual)
- 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.
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.
Detailed description
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 (UC and CD) over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain.
First assessment period: On the first day of the study, we will have a video chat with the participant using one of the telecommunications applications (e.g. skype, zoom, Microsoft team, etc.) and obtain an electric consent form using DocuSign (https://www.docusign.co.uk/). Then, participants will be trained on how to use online validated questionnaires to evaluate their disease activity, symptoms and psychological state, presence or absence of irritable bowel syndrome (IBS), or pain elsewhere. Then, they will be asked to download a mobile phone camera heart rate variability app and be trained to use it. They will also be trained to use the experience sampling method (ESM) to profile gut symptoms and lifestyle via a smartphone app at 10 random times in a day.
After training, participants will fill out baseline online questionnaires using REDCap. Participants will also start answering questionnaires by ESM for 7 days and recording their heart rate (5 minutes) using the app once a day in the morning for 7 days.
2nd-4th assessment periods: Further assessment periods will be scheduled every 6 months. One-two days before each study period begins, we will remind the participants by email or phone call. On day 1, participants fill out the same online questionnaires (except personality, which is a stable trait) followed by 7 days ESM profiling as during their first assessment period. They will also be asked to record heart rate (5 minutes) once a day in the morning for 7days. Each patient will be followed at least 18 months until the 4th assessment period ends.
If patients agree, we will add online questionnaires to patients beyond the life of the grant (at 24 months and 36 months) when they are followed by the IBD BioResource inception study. (ESM and sample collection are not performed after 18 months follow)
This is a collaborative study with the IBD BioResource Inception study. The participants in our study will be asked to participate in the IBD BioResource Inception study as well. Biological data obtained by the BioResource Inception study, which will be used for the analysis.
Study 1B: This is also a collaborative study with the Inception study. Data for 600 patients will still need to be collected by the Inception study when our study starts. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients that are included in the Inception study on a voluntary basis. This will allow us to capture data on almost 600 patients (150 of these will be from study 1A).
Using both our 150 studied patients from study1A and 450 patients in the Inception cohort (study 1B), we will then use cutting edge techniques in machine learning to ascertain if artificial intelligence (AI) can predict individuals who will develop chronic abdominal pain.
Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD (both CD and UC patients). The participants for study 2 are patients who are registered in IBD BOOST study and those for study 3 are patients who are registered in IBD BioResource (but not in IBD Boost study).
The aims are to determine the prevalence of chronic pain in Crohn's and UC patients, the prevalence of comorbid pain and IBS, lifestyle factors, and quality of life. IBD BOOST questionnaire is due to be administered to 10,000 patients. We will invite these patients to complete additional questionnaires not covered by IBD BOOST. We also approach 15,000 patients from IBD BioResourse who are not included in the IBD Boost study and administer questionnaires to them. We will be able to identify risk factors and aid a predictive model from static time point data if a number of those individuals have pain and a number do not. Further, in study 2 and 3, we will be able to determine whether the risk factors identified in study 1A and 1B accurately identify patients with and without chronic pain.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study 1A | – | Other: Assessment of Psychophysiological factors, Biological: Assessment of Biological factors, Genetic: Assessment of Genetics, Behavioral: Assessment of Quality of LifeProspective cohort study with 150 newly diagnosed patients with inflammatory bowel disease |
| Study 1B | – | Other: Assessment of Psychophysiological factors, Genetic: Assessment of Genetics, Behavioral: Assessment of Quality of Life, Biological: Assessment of Biological factorsProspective cohort study with 450 newly diagnosed patients with IBD |
| Study 2 | – | Other: Assessment of Psychophysiological factors, Genetic: Assessment of Genetics, Behavioral: Assessment of Quality of LifeCross-sectional study with 10,000 patients in IBD Boost study |
| Study 3 | – | Other: Assessment of Psychophysiological factors, Genetic: Assessment of Genetics, Behavioral: Assessment of Quality of LifeCross-sectional study with 15,000 patients in IBD BioResource |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Assessment of Psychophysiological factorsInvestigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires. | Other | Study 1A, Study 1B, Study 2, Study 3 |
| Assessment of Biological factorsInvestigating 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) | Biological | Study 1A |
| Assessment of GeneticsGenetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study. | Genetic | Study 1A, Study 1B, Study 2, Study 3 |
| Assessment of Quality of LifeInvestigating QOL by questionnaires. | Behavioural | Study 1A, Study 1B, Study 2, Study 3 |
| Assessment of Biological factorsInvestigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons). | Biological | Study 1B |
Primary outcome
Identification of psychophysiological and biological risk factors for development of chronic abdominal pain
Time frame: 3 years
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
Build predictive models for chronic pain using artificial intelligence and machine learning
Time frame: 3 years
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
5 secondary outcomes
Chronic abdominal pain prevalence
Time frame: 3 years
Co-morbid pain in IBD remission
Time frame: 3 years
Lifestyle factors and quality of life
Time frame: 3 years
Environmental sensitivity
Time frame: 3 years
Prevalence of IBS in IBD remission
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Qasim Aziz principal investigator
Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
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 Diseases, run by Queen Mary University of London at 1 site in United Kingdom.
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 8 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iman Khwaja (02078822655, i.khwaja@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of psychophysiological and biological risk factors for development of chronic abdominal pain (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.