Magnetic Resonance Imaging in Paediatric Constipation

NCT03564249 | Completed

• 1 other identifier: 14GA014
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• EQ-5D-Y questionnaires

  Recorded at 2 time points before and after intervention (one week time frame)

• EQ-VAS

  Measured at 10 time points before and after intervention (one week time frame)

• AC-QoL questionnaire (total score)

  Measured at 2 time points before and after intervention (one week time frame)

• Change in whole gut transit time (hours)

  Measured at 2 time points before and after standard treatment for constipation (approximately 6 months time frame)

• Number of participants completing the study

  Measured at 1 time point after starting the intervention (one week time frame)

Study Arms (2)

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.

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.

Device: MiniCap

Interventions

MiniCap DEVICE

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

Group 1 Young patients with constipation; Group 2 Healthy participants

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Nottingham: collaborator

Study Sites (1)

Nottingham Digestive Diseases Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pauline H Taylor

  Nottingham University Hospitals NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: June 20, 2018
• Study Start: April 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

GB (1)