Inflammatory Bowel DiseasesNIMBUSNCT05673278
Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease Study
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
Rates of inflammatory bowel disease (IBD) are increasing rapidly in children and young people, and targets for management are becoming more demanding, with better control of disease to prevent complications, cancers and surgeries. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Bowel Ultrasound Scan
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2023to 1 May 2024
- How long will I take part?
- 2 Years
- 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 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young people with inflammatory bowel disease under the care of Noah's Ark Children's Hospital for Wales
Who may be able to join
- 50 children visiting hospital for clinical appointments (clinic, infusions, endoscopy etc.) or inpatient in hospital with flare of disease.
- Children with IBD, aged 2-19 years, diagnosed according to the modified Porto criteria
Who cannot join
- Children who do not have inflammatory bowel disease
- Patients who have previously undergone bowel resection (subtotal colectomy, right hemicolectomy or stricturoplasty)
- Patients or families unable to give informed consent
- Children under 2 years of age or patients older than 19 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Noah's Ark Children's Hospital for Wales
Cardiff, CF14 4XW
Zachary Green, MBBCh MRCPCH, 029218 ext. 47816, zacharygreen5@outlook.com
Martin O Edwards, PhD FRCPCH, 029218 ext. 47816, Martin.edwards4@wales.nhs.uk
About this study
Official title: To Examine the Feasibility of Non-Invasive Monitoring With Bowel Ultrasound in Paediatric Inflammatory Bowel Disease and Correlation With Inflammatory Markers, Disease Activity Scores and as a Predictor of Changes in Treatment (NIMBUS)
Rates of inflammatory bowel disease (IBD) are increasing rapidly in children and young people, and targets for management are becoming more demanding, with better control of disease to prevent complications, cancers and surgeries. This project "Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease" or NIMBUS study will aim to explore the possibility of using ultrasound to examine inflammation in this group.
Monitoring inflammation in this population currently is done with regular endoscopy (camera tests) and/ or MRI enterography scans which are invasive, can be uncomfortable, expensive and may have long waiting lists. These studies also require bowel prep, in the form of laxative medicines which can be distressing and cause time off from school. Direct visualisation through ultrasound could allow better monitoring of disease, and is quick, accurate, non-invasive and relatively low-cost. This could also allow for more appropriate medication use and a decrease in over/under use of medicines.
This study will aim to recruit 50 children and young people with inflammatory bowel disease. Each child will have an ultrasound scan after enrolment and the investigators will use the information from these scans, as well as routine blood tests (already taken in normal care) and follow up medical information to explore the use of ultrasound in this group. The investigating team will aim to contribute to the global discussion around this topic and if results are positive will aim to improve monitoring for this population managed at the Noah's Ark Children's Hospital for Wales.
Read the detailed description
This research project will aim to examine the use of ultrasound scans for monitoring disease in paediatric patients with inflammatory bowel disease. This is an area which is being explored in adult research, however it is under-utilised in children and young people.
The null hypothesis in this study is that there is no association between gut ultrasound findings and blood and stool tests of inflammation or disease activity scores in paediatric patients with inflammatory bowel disease. The alternative hypothesis is that there is an association between ultrasound findings and these parameters. Regarding the follow up part of the study, the null hypothesis is that abnormal ultrasound findings have no correlation with either increase or decrease in treatment. The alternative hypothesis is that abnormal ultrasound findings correlate with increase in treatment and normal findings with no change or decrease in treatment.
A prospective feasibility observational methodology will be employed.
In terms of timetable for the study, preparation, including seeking of ethical and research and development alongside study logistics will be undertaken in the first 3 months. Participants will be recruited between months 4 and 18, with data collection and assessment over this time frame. Data will be analysed from months 6 to 24.
Recruitment of children will occur at a routine point of contact with paediatric gastroenterology services, i.e. inpatient review, outpatient attendance for infusion, clinic appointment or endoscopy, or through a virtual recruitment process, where deemed appropriate by the study team. Participants and their families will be provided with age-appropriate information and offered time to review these resources before obtaining consent. When recruited, study team will collect initial recruitment data, i.e. baseline characteristics. The investigating team will aim to arrange for ultrasound appointment as part of routine visit or during inpatient admission. On the day of ultrasound participants will attend the Noah's Ark children's hospital for Wales and scan will be undertaken. The trial team will review recent results (routine tests taken as part of normal care) at this point and then medical notes for clinical outcome up to twelve months after the scan. Results of project will be fed back to participants after study closure.
This project will be open to children with a diagnosis of IBD, according to the modified Porto criteria, aged between 2-19 years old. Only children without these diagnoses, those who have had surgery, which could act as a potential confounder in ultrasound findings, those outside of the age range and those belonging to families unable to give informed consent will be excluded. The information recorded from ultrasound scans will not be made available to the clinical team, therefore recruitment biases will be minimised. The target sample size of 50 children and young people has been set to achieve meaningful results and minimise statistical error. This figure is also based on other fledgling work in this area.
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
- Being tested
- Bowel Ultrasound Scan
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Pediatric ulcerative colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel Ultrasound ScanDiagnostic test
Ultrasound scans will attempt to measure predefined criteria implemented in other research work using bowel ultrasound.
I - Bowel wall thickness II - Colour Doppler signal III - Loss of wall layer stratification IV - Loss of haustration V - Fatty wrapping VI - Motility in terminal ileum (TI) VII - Lymphadenopathy VIII - Abscess IX - Stricture
+ Image quality
| Study group | Role | What they receive |
|---|---|---|
| Children and young people diagnosed with inflammatory bowel disease aged 2-19 years | Diagnosis according to the modified Porto criteria All participants will undergo single ultrasound scan which will be evaluated with medical notes and results from routine care. No new samples will be taken outside of normal care. Receives: Diagnostic Test: Bowel Ultrasound Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility metrics (recruitment, retention/follow up)
Reported as point estimates alongside 95% CIs, and assessed against the traffic light progression criteria:
- Recruitment rate (number screened and approached / number consented): >60% green, 30-60% amber, <30% red
- Retention/follow up rate (number consented / number providing outcome data): >80% green, 70-80% amber, <70% red
- Availability rate of ultrasound scan attendance and specific parameters i.e. ability to obtain for example "loss of bowel wall haustrations" (number scanned/ number providing outcome data): >80% green, 70-80% amber, <70% red
Measured: 12-24 months
Ultrasound parameter score total
Composite measure of bowel wall thickness (BWT), colour doppler signal, loss of wall layer stratification, loss of haustration, fatty wrapping, motility in TI, lymphadenopathy and abscess/ stricture. Bowel wall thickness will be defined as thickness in longitudinal plane + thickness in cross-sectional plane with the total being divided by 2. BWT > 3.0 mm for colonic segments and BWT > 2.0 mm for terminal ileum will be considered abnormal. Colour doppler signal will be graded from 0 to 3. All other parameters are binary and will be scored as either 0 (absent) or 1 (present). A total score will make up the primary outcome measure. Correlations with routine measures of inflammation (i.e blood tests and disease activity scores will be explored).
Measured: 12-24 months
Secondary outcomes (2)
Increase or decrease in medical management
Recorded from medical notes up to 12 months post ultrasound scan. Defined as increase, decrease or remaining unchanged.
Measured: 12 months
Complications
Recorded from medical notes up to 12 months post ultrasound scan. Recording of surgeries, admissions or flare of symptoms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martin O Edwards, PhD FRCPCH, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673278
- Sponsor's protocol ID
- 8497/OCT/2022
- Acronym
- NIMBUS
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Green Z, Towriss C, Ashton JJ, Beattie RM, Evans A, Wahid A, Edwards M. Noninvasive monitoring with bowel ultrasound (NIMBUS) in paediatric inflammatory bowel disease: Feasibility in a single centre. J Pediatr Gastroenterol Nutr. 2025 Oct;81(4):1014-1023. doi: 10.1002/jpn3.70159. Epub 2025 Jul 21.
PubMed 40686225Green Z, Mayberry E, Ashton JJ, Beattie RM, Evans A, Wahid A, Edwards MO. NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease. BMJ Open. 2023 Dec 14;13(12):e078675. doi: 10.1136/bmjopen-2023-078675.
PubMed 38101846
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Examine the Feasibility of Non-Invasive Monitoring With Bowel Ultrasound in Paediatric Inflammatory Bowel Disease and Correlation With Inflammatory Markers, Disease Activity Scores and as a Predictor of Changes in Treatment (NIMBUS)
- ClinicalTrials.gov ID
- NCT05673278
- Acronym / sponsor ID
- NIMBUS / 8497/OCT/2022
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, Pediatric Crohns Disease, Pediatric Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 Jan 2023 (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.
Rates of inflammatory bowel disease (IBD) are increasing rapidly in children and young people, and targets for management are becoming more demanding, with better control of disease to prevent complications, cancers and surgeries. This project "Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease" or NIMBUS study will aim to explore the possibility of using ultrasound to examine inflammation in this group.
Monitoring inflammation in this population currently is done with regular endoscopy (camera tests) and/ or MRI enterography scans which are invasive, can be uncomfortable, expensive and may have long waiting lists. These studies also require bowel prep, in the form of laxative medicines which can be distressing and cause time off from school. Direct visualisation through ultrasound could allow better monitoring of disease, and is quick, accurate, non-invasive and relatively low-cost. This could also allow for more appropriate medication use and a decrease in over/under use of medicines.
This study will aim to recruit 50 children and young people with inflammatory bowel disease. Each child will have an ultrasound scan after enrolment and the investigators will use the information from these scans, as well as routine blood tests (already taken in normal care) and follow up medical information to explore the use of ultrasound in this group. The investigating team will aim to contribute to the global discussion around this topic and if results are positive will aim to improve monitoring for this population managed at the Noah's Ark Children's Hospital for Wales.
Detailed description
This research project will aim to examine the use of ultrasound scans for monitoring disease in paediatric patients with inflammatory bowel disease. This is an area which is being explored in adult research, however it is under-utilised in children and young people.
The null hypothesis in this study is that there is no association between gut ultrasound findings and blood and stool tests of inflammation or disease activity scores in paediatric patients with inflammatory bowel disease. The alternative hypothesis is that there is an association between ultrasound findings and these parameters. Regarding the follow up part of the study, the null hypothesis is that abnormal ultrasound findings have no correlation with either increase or decrease in treatment. The alternative hypothesis is that abnormal ultrasound findings correlate with increase in treatment and normal findings with no change or decrease in treatment.
A prospective feasibility observational methodology will be employed.
In terms of timetable for the study, preparation, including seeking of ethical and research and development alongside study logistics will be undertaken in the first 3 months. Participants will be recruited between months 4 and 18, with data collection and assessment over this time frame. Data will be analysed from months 6 to 24.
Recruitment of children will occur at a routine point of contact with paediatric gastroenterology services, i.e. inpatient review, outpatient attendance for infusion, clinic appointment or endoscopy, or through a virtual recruitment process, where deemed appropriate by the study team. Participants and their families will be provided with age-appropriate information and offered time to review these resources before obtaining consent. When recruited, study team will collect initial recruitment data, i.e. baseline characteristics. The investigating team will aim to arrange for ultrasound appointment as part of routine visit or during inpatient admission. On the day of ultrasound participants will attend the Noah's Ark children's hospital for Wales and scan will be undertaken. The trial team will review recent results (routine tests taken as part of normal care) at this point and then medical notes for clinical outcome up to twelve months after the scan. Results of project will be fed back to participants after study closure.
This project will be open to children with a diagnosis of IBD, according to the modified Porto criteria, aged between 2-19 years old. Only children without these diagnoses, those who have had surgery, which could act as a potential confounder in ultrasound findings, those outside of the age range and those belonging to families unable to give informed consent will be excluded. The information recorded from ultrasound scans will not be made available to the clinical team, therefore recruitment biases will be minimised. The target sample size of 50 children and young people has been set to achieve meaningful results and minimise statistical error. This figure is also based on other fledgling work in this area.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and young people diagnosed with inflammatory bowel disease aged 2-19 years | – | Diagnostic Test: Bowel Ultrasound ScanDiagnosis according to the modified Porto criteria All participants will undergo single ultrasound scan which will be evaluated with medical notes and results from routine care. No new samples will be taken outside of normal care. |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young people with inflammatory bowel disease under the care of Noah's Ark Children's Hospital for Wales
Key inclusion criteria (2 listed)
- 50 children visiting hospital for clinical appointments (clinic, infusions, endoscopy etc.) or inpatient in hospital with flare of disease.
- Children with IBD, aged 2-19 years, diagnosed according to the modified Porto criteria
Key exclusion criteria (4 listed)
- Children who do not have inflammatory bowel disease
- Patients who have previously undergone bowel resection (subtotal colectomy, right hemicolectomy or stricturoplasty)
- Patients or families unable to give informed consent
- Children under 2 years of age or patients older than 19 years
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 |
|---|---|---|
| Bowel Ultrasound ScanUltrasound scans will attempt to measure predefined criteria implemented in other research work using bowel ultrasound. I - Bowel wall thickness II - Colour Doppler signal III - Loss of wall layer stratification IV - Loss of haustration V - Fatty wrapping VI - Motility in terminal ileum (TI) VII - Lymphadenopathy VIII - Abscess IX - Stricture + Image quality | Diagnostic test | Children and young people diagnosed with inflammatory bowel disease aged 2-19 years |
Primary outcome
Feasibility metrics (recruitment, retention/follow up)
Time frame: 12-24 months
Reported as point estimates alongside 95% CIs, and assessed against the traffic light progression criteria: * Recruitment rate (number screened and approached / number consented): >60% green, 30-60% amber, <30% red * Retention/follow up rate (number consented / number providing outcome data): >80% green, 70-80% amber, <70% red * Availability rate of ultrasound scan attendance and specific parameters i.e. ability to obtain for example "loss of bowel wall haustrations" (number scanned/ number providing outcome data): >80% green, 70-80% amber, <70% red
Ultrasound parameter score total
Time frame: 12-24 months
Composite measure of bowel wall thickness (BWT), colour doppler signal, loss of wall layer stratification, loss of haustration, fatty wrapping, motility in TI, lymphadenopathy and abscess/ stricture. Bowel wall thickness will be defined as thickness in longitudinal plane + thickness in cross-sectional plane with the total being divided by 2. BWT > 3.0 mm for colonic segments and BWT > 2.0 mm for terminal ileum will be considered abnormal. Colour doppler signal will be graded from 0 to 3. All other parameters are binary and will be scored as either 0 (absent) or 1 (present). A total score will make up the primary outcome measure. Correlations with routine measures of inflammation (i.e blood tests and disease activity scores will be explored).
2 secondary outcomes
Increase or decrease in medical management
Time frame: 12 months
Complications
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 40686225Green Z, Towriss C, Ashton JJ, Beattie RM, Evans A, Wahid A, Edwards M. Noninvasive monitoring with bowel ultrasound (NIMBUS) in paediatric inflammatory bowel disease: Feasibility in a single centre. J Pediatr Gastroenterol Nutr. 2025 Oct;81(4):1014-1023. doi: 10.1002/jpn3.70159. Epub 2025 Jul 21.
- Derived from this study: PubMed 38101846Green Z, Mayberry E, Ashton JJ, Beattie RM, Evans A, Wahid A, Edwards MO. NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease. BMJ Open. 2023 Dec 14;13(12):e078675. doi: 10.1136/bmjopen-2023-078675.
- 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.
Martin O Edwards, PhD FRCPCH principal investigator
Cardiff and Vale University Health Board
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 and Ulcerative Colitis, run by Cardiff and Vale University Health Board 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 2 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zachary Green, MBBCh MRCPCH (029218 ext. 47816, zacharygreen5@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility metrics (recruitment, retention/follow up) (time frame: 12-24 months). 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?
On the ClinicalTrials.gov record for NCT05673278, which also lists 2 linked publications.
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 31 Aug 2023.