Magnetic Resonance Imaging in Paediatric Constipation (MAGIC)

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Device: MiniCap

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Nottingham Digestive Diseases Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Young patients with constipation; 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.	Device: MiniCap; 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
Experimental: Group 2 Healthy participants; 25 young healthy controls matched for gender. They will undergo the new MRI gastrointestinal transit test (MiniCap) once.	Device: MiniCap; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut transit time (hours)	Whole gut transit time measured from the number of MiniCap retained in the bowel as detected by MRI imaging	1 week time frame

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 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 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 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 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 at 1 time point after starting the intervention (one week time frame)

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Collaborators: University of Nottingham
• Investigators: Study Director: Pauline H Taylor, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 14GA014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No