NCT03564249: MAGIC

Magnetic Resonance Imaging in Paediatric Constipation

Completed NA Last updated 16 August 2019

What this trial tests

NA trial testing MiniCap in Constipation in 42 participants. Completed in 30 June 2019.

Timeline

15 April 2018

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Nottingham University Hospitals NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	42
Start date	15 April 2018
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• MiniCap

Conditions studied

• Constipation — all drugs for Constipation →

Sponsor

Nottingham University Hospitals NHS Trust

Who can join

Adults 7 to 18, any sex, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

This study is the first feasibility test of the new mini-capsules in paediatric constipation. 25 patients and 25 healthy controls will participate. The study will measure gut transit time using MRI and the mini-capsules before and after the young patients receive standard treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. "A little (PPI) MAGIC can take you a long way" : involving children and young people in research from inception of a novel medical device to multi-centre clinical trial Roald Dahl, James and the Giant Peach (1961).
   Abrehart N, Frost K, Young Persons Advisory Group, Harris R, et al · · 2021 · cited 10× · PMID 33407935 · DOI 10.1186/s40900-020-00243-0
2. Feasibility Study of a New Magnetic Resonance Imaging Mini-capsule Device to Measure Whole Gut Transit Time in Paediatric Constipation.
   Sharif H, Abrehart N, Hoad CL, Murray K, et al · · 2020 · cited 10× · PMID 33093366 · DOI 10.1097/mpg.0000000000002910
3. Colonic Volume Changes in Paediatric Constipation Compared to Normal Values Measured Using MRI.
   Sharif H, Hoad CL, Abrehart N, Gowland PA, et al · · 2021 · cited 9× · PMID 34071217 · DOI 10.3390/diagnostics11060974
4. Colon length in pediatric health and constipation measured using magnetic resonance imaging and three dimensional skeletonization.
   Sharif H, Hoad CL, Abrehart N, Gowland PA, et al · · 2024 · cited 7× · PMID 38165858 · DOI 10.1371/journal.pone.0296311