Constipation
Conditions
Keywords
constipation, pediatric, transit
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
Interventions
DEVICETransiCap
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.
Sponsors
University of Nottingham
Nottingham University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of bowel movements | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Device Events | Day 7, 6 and 12 months | Number of Adverse devise events recorded |
| Whole gut transit time | Day 7 | Whole gut transit time (in hours) measured using the MRI visible mini-capsules |
| EQ-VAS | Day 7, 6 months and 12 months | Visual analogue scale for health on the day |
| Stool form | Day 7, 6 months and 12 months | Bristol scale to measure stool form |
| Serious Adverse Events | 12 months | Number of Serious Adverse Events (SAEs) |
| AC-QoL | 12 | Adults (parents/carers) quality of life questionnaire score |
| Adverse Events | 12 months | Number of Adverse Events (AEs) |
| Number of Mini-capsules swallowed | Day 4 | Number of Mini-capsules swallowed by the participants |
Countries
United Kingdom
Outcome results
None listed