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Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2) (MAGIC2)

Primary Purpose

Constipation

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
TransiCap
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Constipation focused on measuring constipation, pediatric, transit

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Whole gut transit time
Whole gut transit time (in hours) measured using the MRI visible mini-capsules
EQ-VAS
Visual analogue scale for health on the day
Adverse Events
Number of Adverse Events (AEs)
Serious Adverse Events
Number of Serious Adverse Events (SAEs)
Stool form
Bristol scale to measure stool form
Number of Mini-capsules swallowed
Number of Mini-capsules swallowed by the participants
Adverse Device Events
Number of Adverse devise events recorded
AC-QoL
Adults (parents/carers) quality of life questionnaire score

Full Information

First Posted
March 24, 2021
Last Updated
August 30, 2023
Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT05082129
Brief Title
Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)
Acronym
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
due to the impact of the COVID19 pandemic on MRI service provision, NHS hospitals were unable to provide the resources to conduct the study
Study Start Date
July 12, 2021 (Anticipated)
Primary Completion Date
July 12, 2023 (Anticipated)
Study Completion Date
July 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, pediatric, transit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TransiCap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of bowel movements
Description
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
Time Frame
12 months
Title
Number of bowel incontinence episodes
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Whole gut transit time
Description
Whole gut transit time (in hours) measured using the MRI visible mini-capsules
Time Frame
Day 7
Title
EQ-VAS
Description
Visual analogue scale for health on the day
Time Frame
Day 7, 6 months and 12 months
Title
Adverse Events
Description
Number of Adverse Events (AEs)
Time Frame
12 months
Title
Serious Adverse Events
Description
Number of Serious Adverse Events (SAEs)
Time Frame
12 months
Title
Stool form
Description
Bristol scale to measure stool form
Time Frame
Day 7, 6 months and 12 months
Title
Number of Mini-capsules swallowed
Description
Number of Mini-capsules swallowed by the participants
Time Frame
Day 4
Title
Adverse Device Events
Description
Number of Adverse devise events recorded
Time Frame
Day 7, 6 and 12 months
Title
AC-QoL
Description
Adults (parents/carers) quality of life questionnaire score
Time Frame
12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Hyman-Taylor
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon completion external parties may request access to the data. Access to the data will be reviewed and approved by the data monitoring committee, funder and sponsor.
IPD Sharing Time Frame
Upon completion of the study.
IPD Sharing Access Criteria
to be determined

Learn more about this trial

Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

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