Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

Constipation Clinical Trial

— 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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05082129
• Other study ID #: 19GA038
• Status: Withdrawn
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: July 12, 2023

Study information

• Verified date: March 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

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