Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

Nottingham University Hospitals NHS Trust

Overview

Constipation in children is a common problem. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. A "gut transit time" test can add information to help choose the best therapy but this is often not carried out because of the unsuitable radiation dose involved in the current methods such as X-ray. A new Magnetic Resonance Imaging (MRI) method to measure gut transit time using inert mini-capsules, the size of small pine nuts, has recently been developed and successfully trialled during a feasibility study. This main multicentre study will trial the mini-capsules in 436 paediatric constipation patients.

A fully powered, multi-centre, open label, pragmatic Randomised Controlled Trial (RCT) to test the use of the TransiCap MRI visible capsules to inform treatment selection and whether this leads to a change in rate of "treatment success" at 12 months after diagnosis. Two study arms will include 436 young patients that present at secondary or tertiary care with constipation. All participants will receive the TransiCap MRI Visible Capsules and the MRI scans at presentation, but only the participants in the intervention arm will have the results of their scan shared with the standard care team immediately. The intervention arm will therefore receive treatment which is informed by the TransiCap MRI transit time test. The participants in the control arm will instead receive standard care not informed by theTransiCap MRI visible capsules. The results of the scans will be shared with the standard care team after the patient's follow up of 12 months is complete. All participants will receive the TransiCap MRI visible capsules and the MRI scans

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Constipation

Interventions

TransiCapDEVICE

The TransiCap device consists of small, completely inert mini-capsules that, once ingested, can be imaged inside the gastrointestinal tract using MRI, thereby creating a new MRI alternative to the radiopaque marker X-ray test to measure gut transit. The MRI mini- capsules are visualised in the gut using a single fat, water, in-phase and out-of-phase scan.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Children aged 7 - 18 years old Able to give assent/consent or have a parent/carer able to give informed consent Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation. Children diagnosed with clinical diagnosis of constipation Exclusion Criteria: The participant may not enter the clinical investigation if ANY of the following apply: Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self-reported. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as colectomy or small bowel resection. Existing ACE procedure before the first MRI scan. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury. Inability to lie flat and relatively still for less than 5 minutes Poor understanding of English language Current diagnosis of COVID 19. The following disease or disorder; Bowel Stricture disease, Crohn's or any difficulty in swallowing (Dysphagia) Hirschsprung disease, congenital anorectal malformations, Paediatric Pseudo-obstruction syndrome Currently using the following drugs influencing motility: 1. Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramoland) 2. Antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide) Participants who have participated in another research clinical investigation involving an investigational product in the past 12 weeks. 4 or more bowel movements in one week and no episodes of bowel incontinence in one week (if these are reported in the participant's medical notes. Absence of this information should not warrant exclusion)

Locations (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Outcomes

Primary Outcomes

Number of bowel movements

This outcome measure will be combined with the number of bowel incontinence episodes outcome to define the overall Treatment Success (yes/no) defined (from Rome IV criteria) as the patient achieving 3 or more bowel movements in one week and/or no episodes of bowel incontinence in one week at 12 months after the MRI study

Time frame: 12 months

Number of bowel incontinence episodes

This outcome measure will be combined with the number of bowel movements outcome to define the overall Treatment Success (yes/no) defined (from Rome IV criteria) as the patient achieving 3 or more bowel movements in one week and/or no episodes of bowel incontinence in one week at 12 months after the MRI study

Time frame: 12 months

Secondary Outcomes

Whole gut transit time

Whole gut transit time (in hours) measured using the MRI visible mini-capsules

Time frame: Day 7

EQ-VAS

Visual analogue scale for health on the day

Time frame: Day 7, 6 months and 12 months

Adverse Events

Number of Adverse Events (AEs)

Time frame: 12 months

Serious Adverse Events

Number of Serious Adverse Events (SAEs)

Time frame: 12 months

Stool form

Bristol scale to measure stool form

Time frame: Day 7, 6 months and 12 months

Number of Mini-capsules swallowed

Data from ClinicalTrials.gov

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