Constipation Clinical Trial
— MAGICOfficial title:
A Feasibility Study to Measure Gut Transit in Paediatric Constipation Using Novel Mini-capsules and Magnetic Resonance Imaging
NCT number | NCT03564249 |
Other study ID # | 14GA014 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 15, 2018 |
Est. completion date | June 30, 2019 |
Verified date | August 2019 |
Source | Nottingham University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham Digestive Diseases Centre | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust | University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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