ConstipationMAGICNCT03564249
Magnetic Resonance Imaging in Paediatric Constipation
A study testing MiniCap 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- MiniCap
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2018to 30 Jun 2019
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 7 - 18 years old
- Male or female
- Able to give assent or have a parent able to give informed consent
- Willing to allow their GP or consultant, if appropriate, to be notified of participation in the clinical investigation
- Presenting with intractable constipation at secondary or tertiary care and considered for possible treatment which may include new drugs or procedures (Group1 only)
- Healthy bowel habit and does not suffer from constipation or diarrhoea (Group 2 only)
Who cannot join
- Female participants who are pregnant, lactating or planning pregnancy during the course of the investigation.
- Any history of gastrointestinal surgery such as colectomy or small bowel resection.
- Existing ACE procedure before the first MRI scan (Group 1 only)
- Significant renal or hepatic impairment
- Contraindications for MRI scanning such as metallic implants and penetrating eye injury.
- Inability to lie flat and relatively still for less than 5 minutes
Show all 9Show fewer
- Poor understanding of English language
- Any other significant disease or disorder (other than intractable constipation for Group 1)
- Participation in another research clinical investigation involving an investigational product in the past 12 weeks.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Diseases Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: A Feasibility Study to Measure Gut Transit in Paediatric Constipation Using Novel Mini-capsules and Magnetic Resonance Imaging
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.
This study is the first feasibility test of the new mini-capsules in paediatric constipation. 25 patients and 25 healthy controls will participate. The study will measure gut transit time using MRI and the mini-capsules before and after the young patients receive standard treatment.
Read the detailed description
One in ten children worldwide has constipation and it becomes chronic in 30% of these children, affecting their and their families' well-being. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. If the doctors could send the children for a quick test that indicates the time that food takes to travel through the gut (the "gut transit time"), they could use this information to help choose the best therapy, for example to decide if a patient needs surgery. The test could also be used to follow up the effects of different treatments. Gut transit time is often not tested due to the unsuitable radiation dose involved in the current methods such as X-ray. Doctors' decisions have to rely mostly on symptoms, leading to repeated appointments, frustration and a waste of NHS money.
A new method to measure gut transit time using mini-capsules, the size of small pine nuts, has recently been developed. The mini-capsules are swallowed but do not dissolve and their journey through the gut is imaged using Magnetic Resonance Imaging (MRI). From the images doctors can determine the gut transit time. MRI is harmless and can be used repeatedly to follow up the response to treatment.
This study will test these new mini-capsules to determine their suitability for paediatric use. Areas of interest are ease of imaging in the gut using MRI and whether they are small enough such that their emptying from the stomach and transit through the gut are similar to food. The study will test the mini-capsules in children with constipation, to measure gut transit time before and after they receive their usual treatment from their doctors. This will assess if the mini-capsules can detect changes in treatment and will make them clinically useful.
- Conditions
- Constipation
- Being tested
- MiniCap
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniCapDevice
The MiniCap 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 |
|---|---|---|
| Group 1 Young patients with constipation | Experimental | 25 young patients that present at secondary or tertiary care with intractable constipation. They will undergo the new MRI gastrointestinal transit test (MiniCap) once before standard treatment for constipation and once after the treatment. Receives: Device: MiniCap |
| Group 2 Healthy participants | Experimental | 25 young healthy controls matched for gender. They will undergo the new MRI gastrointestinal transit test (MiniCap) once. Receives: Device: MiniCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time (hours)
Whole gut transit time measured from the number of MiniCap retained in the bowel as detected by MRI imaging
Measured: 1 week time frame
Secondary outcomes (6)
EQ-5D-Y questionnaires
The EuroQOL five dimensions questionnaire for young (EQ-5D-Y) is the EuroQuol descriptive system for children and adolescents. It describes 5 dimensions of Quality of Life: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The younger patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the younger patient's health state. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient or respondent. For instance, a fairly healthy person may have an EQ-5D health state of 1-2-1-1-1. The higher the digits the worse the health state.
Measured: Recorded at 2 time points before and after intervention (one week time frame)
EQ-VAS
The EuroQOL visual analogue scale (EQ-VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The scale is numbered from 1 to 100 with 100 being the best health and 0 the worst health.
Measured: Measured at 10 time points before and after intervention (one week time frame)
AC-QoL questionnaire (total score)
The Adult carers quality of life (AC-QoL questionnaire) is a questionnaire for use with adult carers that measures quality of life in eight separate domains: support for caring; caring choice; caring stress; money matters; personal growth; sense of value; ability to care; and carer satisfaction. The questions are designed for scoring between 0 to 3 (from never to always). The composite score reflects the overall quality of life with low scores 0-40 representing a low reported quality of life and greater than 81 a high reported quality of life.
Measured: Measured at 2 time points before and after intervention (one week time frame)
Change in whole gut transit time (hours)
Change in whole gut transit time measured from the number of MiniCap retained in the bowel as detected by MRI imaging before and after standard treatment for constipation
Measured: Measured at 2 time points before and after standard treatment for constipation (approximately 6 months time frame)
Number of participants completing the study
The number of participants completing the entire study will be used to assess feasibility
Measured: Measured at 1 time point after starting the intervention (one week time frame)
Number of adverse events
The number of adverse events will be used to assess safety
Measured: Measured at 1 time point after starting the intervention (one week time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start15 Apr 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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 H Taylor, Study director, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564249
- Sponsor's protocol ID
- 14GA014
- Acronym
- MAGIC
- Status last verified
- Aug 2019
- First submitted
- 14 Mar 2018
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Measure Gut Transit in Paediatric Constipation Using Novel Mini-capsules and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03564249
- Acronym / sponsor ID
- MAGIC / 14GA014
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Jun 2018 (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.
This study is the first feasibility test of the new mini-capsules in paediatric constipation. 25 patients and 25 healthy controls will participate. The study will measure gut transit time using MRI and the mini-capsules before and after the young patients receive standard treatment.
Detailed description
One in ten children worldwide has constipation and it becomes chronic in 30% of these children, affecting their and their families' well-being. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. If the doctors could send the children for a quick test that indicates the time that food takes to travel through the gut (the "gut transit time"), they could use this information to help choose the best therapy, for example to decide if a patient needs surgery. The test could also be used to follow up the effects of different treatments. Gut transit time is often not tested due to the unsuitable radiation dose involved in the current methods such as X-ray. Doctors' decisions have to rely mostly on symptoms, leading to repeated appointments, frustration and a waste of NHS money.
A new method to measure gut transit time using mini-capsules, the size of small pine nuts, has recently been developed. The mini-capsules are swallowed but do not dissolve and their journey through the gut is imaged using Magnetic Resonance Imaging (MRI). From the images doctors can determine the gut transit time. MRI is harmless and can be used repeatedly to follow up the response to treatment.
This study will test these new mini-capsules to determine their suitability for paediatric use. Areas of interest are ease of imaging in the gut using MRI and whether they are small enough such that their emptying from the stomach and transit through the gut are similar to food. The study will test the mini-capsules in children with constipation, to measure gut transit time before and after they receive their usual treatment from their doctors. This will assess if the mini-capsules can detect changes in treatment and will make them clinically useful.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Young patients with constipation | Experimental | Device: MiniCap25 young patients that present at secondary or tertiary care with intractable constipation. They will undergo the new MRI gastrointestinal transit test (MiniCap) once before standard treatment for constipation and once after the treatment. |
| Group 2 Healthy participants | Experimental | Device: MiniCap25 young healthy controls matched for gender. They will undergo the new MRI gastrointestinal transit test (MiniCap) once. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged 7 - 18 years old
- Male or female
- Able to give assent or have a parent able to give informed consent
- Willing to allow their GP or consultant, if appropriate, to be notified of participation in the clinical investigation
- Presenting with intractable constipation at secondary or tertiary care and considered for possible treatment which may include new drugs or procedures (Group1 only)
Key exclusion criteria (9 listed)
- Female participants who are pregnant, lactating or planning pregnancy during the course of the investigation.
- Any history of gastrointestinal surgery such as colectomy or small bowel resection.
- Existing ACE procedure before the first MRI scan (Group 1 only)
- Significant renal or hepatic impairment
- Contraindications for MRI scanning such as metallic implants and penetrating eye injury.
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 |
|---|---|---|
| MiniCapThe MiniCap 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 | Group 1 Young patients with constipation, Group 2 Healthy participants |
Primary outcome
Whole gut transit time (hours)
Time frame: 1 week time frame
Whole gut transit time measured from the number of MiniCap retained in the bowel as detected by MRI imaging
6 secondary outcomes
EQ-5D-Y questionnaires
Time frame: Recorded at 2 time points before and after intervention (one week time frame)
EQ-VAS
Time frame: Measured at 10 time points before and after intervention (one week time frame)
AC-QoL questionnaire (total score)
Time frame: Measured at 2 time points before and after intervention (one week time frame)
Change in whole gut transit time (hours)
Time frame: Measured at 2 time points before and after standard treatment for constipation (approximately 6 months time frame)
Number of participants completing the study
Time frame: Measured at 1 time point after starting the intervention (one week time frame)
Number of adverse events
Time frame: Measured at 1 time point after starting the intervention (one week time frame)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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 H 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 MiniCap 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 6 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: finished, as of the sponsor's last update on 16 Aug 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whole gut transit time (hours) (time frame: 1 week time frame). 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 16 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.