Non-Invasive Monitoring Through Bowel Ultrasound in Paediatric Inflammatory Bowel Disease Study

NCT05673278 | Unknown DMC

• 1 other identifier: 8497/OCT/2022
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; Pediatric Crohns Disease; Pediatric Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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).

  12-24 months

Secondary Outcomes (2)

• Increase or decrease in medical management

  12 months

• Complications

  12 months

Study Arms (1)

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.

Diagnostic Test: Bowel Ultrasound Scan

Interventions

Bowel Ultrasound Scan DIAGNOSTIC_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

Children and young people diagnosed with inflammatory bowel disease aged 2-19 years

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and young people with inflammatory bowel disease under the care of Noah's Ark Children's Hospital for Wales

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Noah's Ark Children's Hospital for Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 40686225 DERIVED

• 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.

  PMID: 38101846 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Pediatric ulcerative colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Martin O Edwards, PhD FRCPCH

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Green, MBBCh MRCPCH

CONTACT

029218; zacharygreen5@outlook.com

Martin O Edwards, PhD FRCPCH

CONTACT

029218; Martin.edwards4@wales.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)