Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

NCT05082129 | Withdrawn DMC

• 1 other identifier: 19GA038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

constipation; pediatric; transit

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Whole gut transit time

  Day 7

• EQ-VAS

  Day 7, 6 months and 12 months

• Adverse Events

  12 months

• Serious Adverse Events

  12 months

• Stool form

  Day 7, 6 months and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

EXPERIMENTAL

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

Interventions

TransiCap DEVICE

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.

Control; Intervention

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramoland)
• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Nottingham: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pauline Hyman-Taylor

  Nottingham University Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: October 18, 2021
• Study Start: July 12, 2021
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: September 5, 2023

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon completion of the study.
• Access Criteria: to be determined

Locations

GB (1)