Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2) (MAGIC2)

A Multicentre Pragmatic Clinical Investigation to Assess the Efficacy of TransiCap MRI Marker Device in Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

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.

Study Overview

• Status: Withdrawn
• Conditions: Constipation
• Intervention / Treatment: Device: TransiCap

Detailed Description

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention will consist of young patients with constipation presenting at secondary and tertiary care with intractable constipation. They will undergo the MRI gastrointestinal transit test (TransiCap). Their results will be shared with the patients after both MRI scans are preformed and results calculated. Their treatment selection will therefore be informed by the TransiCap results.	Device: TransiCap; 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.
Experimental: Control; The control arm will consist of young patients with constipation presenting at secondary and tertiary care with intractable constipation. They will undergo the MRI gastrointestinal transit test (TransiCap). The patients will undergo 2 MRI scans but their results will be shared with the patients after 12 months has elapsed. They will receive standard care treatment not informed by the TransiCap results.	Device: TransiCap; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut transit time	Whole gut transit time (in hours) measured using the MRI visible mini-capsules	Day 7
EQ-VAS	Visual analogue scale for health on the day	Day 7, 6 months and 12 months
Adverse Events	Number of Adverse Events (AEs)	12 months
Serious Adverse Events	Number of Serious Adverse Events (SAEs)	12 months
Stool form	Bristol scale to measure stool form	Day 7, 6 months and 12 months
Number of Mini-capsules swallowed	Number of Mini-capsules swallowed by the participants	Day 4
Adverse Device Events	Number of Adverse devise events recorded	Day 7, 6 and 12 months
AC-QoL	Adults (parents/carers) quality of life questionnaire score	12

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Collaborators: University of Nottingham
• Investigators: Study Director: Pauline Hyman-Taylor, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): July 12, 2021
• Primary Completion (Estimated): July 12, 2023
• Study Completion (Estimated): July 12, 2023

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: pediatric; constipation; transit
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 19GA038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon completion external parties may request access to the data. Access to the data will be reviewed and approved by the data monitoring committee, funder and sponsor.
• IPD Sharing Time Frame: Upon completion of the study.
• IPD Sharing Access Criteria: to be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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