NIMBUS
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)
Sponsor study identifier
observational
50
1 country
1
Study Start
May 1, 2023
Actual (reported)Primary Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2022
Actual (reported)January 6, 2023
Actual (reported)May 1, 2023
Actual (reported)May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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).
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.
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
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Children and young people with inflammatory bowel disease under the care of Noah's Ark Children's Hospital for Wales
Noah's Ark Children's Hospital for Wales
Cardiff, CF14 4XW, United Kingdom
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.
Green 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.
Martin O Edwards, PhD FRCPCH
Cardiff and Vale University Health Board
First Submitted
December 21, 2022
First Posted
January 6, 2023
Study Start
May 1, 2023
Actual (reported)Primary Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
12-24 months
Increase or decrease in medical management
12 months
Complications
12 months
Contact the study team to confirm eligibility.
Study Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 31, 2023
Record last verified: 2022-11
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