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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Pediatric Ulcerative Colitis; Pediatric Crohns Disease
• Intervention / Treatment: Diagnostic test: Bowel Ultrasound Scan

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Zachary Green, MBBCh MRCPCH; Phone Number: 47816 029218; Email: zacharygreen5@outlook.com
• Study Contact Backup: Name: Martin O Edwards, PhD FRCPCH; Phone Number: 47816 029218; Email: Martin.edwards4@wales.nhs.uk

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Recruiting
    • Noah's Ark Children's Hospital for Wales
    • Contact: Zachary Green, MBBCh MRCPCH; Phone Number: 47816 029218; Email: zacharygreen5@outlook.com
    • Contact: Martin O Edwards, PhD FRCPCH; Phone Number: 47816 029218; Email: Martin.edwards4@wales.nhs.uk
    • Sub-Investigator: Zachary Green, MBBCh MRCPCH
    • Principal Investigator: Martin Edwards, PhD FRCPCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase or decrease in medical management	Recorded from medical notes up to 12 months post ultrasound scan. Defined as increase, decrease or remaining unchanged.	12 months
Complications	Recorded from medical notes up to 12 months post ultrasound scan. Recording of surgeries, admissions or flare of symptoms.	12 months

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Investigators: Principal Investigator: Martin O Edwards, PhD FRCPCH, Cardiff and Vale University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 8497/OCT/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No