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Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

NCT05082129 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Pauline Hyman-Taylor · Nottingham University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2023-07-12
Completion
2023-07-12

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082129 on ClinicalTrials.gov