ConstipationMAGIC2NCT05082129
Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)
A study testing TransiCap in people with Constipation, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Constipation
- What is being tested?
- TransiCap
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2021to 12 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: A Multicentre Pragmatic Clinical Investigation to Assess the Efficacy of TransiCap MRI Marker Device in Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)
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.
Read the 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
- Conditions
- Constipation
- Being tested
- TransiCap
- Keywords
- constipation, pediatric, transit
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransiCapDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: TransiCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (8)
Whole gut transit time
Whole gut transit time (in hours) measured using the MRI visible mini-capsules
Measured: Day 7
EQ-VAS
Visual analogue scale for health on the day
Measured: Day 7, 6 months and 12 months
Adverse Events
Number of Adverse Events (AEs)
Measured: 12 months
Serious Adverse Events
Number of Serious Adverse Events (SAEs)
Measured: 12 months
Stool form
Bristol scale to measure stool form
Measured: Day 7, 6 months and 12 months
Number of Mini-capsules swallowed
Number of Mini-capsules swallowed by the participants
Measured: Day 4
Adverse Device Events
Number of Adverse devise events recorded
Measured: Day 7, 6 and 12 months
AC-QoL
Adults (parents/carers) quality of life questionnaire score
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start12 Jul 2021 (estimated)
- Primary completion12 Jul 2023 (estimated)
- Study completion12 Jul 2023 (estimated)
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Pauline Hyman-Taylor, Study director, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082129
- Sponsor's protocol ID
- 19GA038
- Acronym
- MAGIC2
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Pragmatic Clinical Investigation to Assess the Efficacy of TransiCap MRI Marker Device in Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)
- ClinicalTrials.gov ID
- NCT05082129
- Acronym / sponsor ID
- MAGIC2 / 19GA038
- Conditions
- Constipation
- Keywords
- constipation, pediatric, transit
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 12 Jul 2021 (estimated)
- Primary completion
- 12 Jul 2023 (estimated)
- Study completion
- 12 Jul 2023 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: TransiCapThe 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. |
| Control | Experimental | Device: TransiCapThe 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co-codamol and codydramoland)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransiCapThe 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. | Device | Control, Intervention |
Primary outcome
Number of bowel movements
Time frame: 12 months
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
Time frame: 12 months
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
8 secondary outcomes
Whole gut transit time
Time frame: Day 7
EQ-VAS
Time frame: Day 7, 6 months and 12 months
Adverse Events
Time frame: 12 months
Serious Adverse Events
Time frame: 12 months
Stool form
Time frame: Day 7, 6 months and 12 months
Number of Mini-capsules swallowed
Time frame: Day 4
Adverse Device Events
Time frame: Day 7, 6 and 12 months
AC-QoL
Time frame: 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Hyman-Taylor study director
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TransiCap in people with Constipation, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bowel movements (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.