Clinical trial NCT05082129: Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)
Official title: A Multicentre Pragmatic Clinical Investigation to Assess the Efficacy of TransiCap MRI Marker Device in Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Constipation
Keywords: constipation
pediatric
transit
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2021-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Number of bowel movements
timeFrame: 12 months
measure: Number of bowel incontinence episodes
timeFrame: 12 months
Secondary outcomes:
measure: Whole gut transit time
timeFrame: Day 7
measure: EQ-VAS
timeFrame: Day 7, 6 months and 12 months
measure: Adverse Events
timeFrame: 12 months
measure: Serious Adverse Events
timeFrame: 12 months
measure: Stool form
timeFrame: Day 7, 6 months and 12 months
measure: Number of Mini-capsules swallowed
timeFrame: Day 4
measure: Adverse Device Events
timeFrame: Day 7, 6 and 12 months
measure: AC-QoL
timeFrame: 12
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Pauline Hyman-Taylor
role: STUDY_DIRECTOR
References: