Magnetic Resonance Imaging in Paediatric Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

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.
    

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.
    

Intervention name(s): MiniCap
Intervention type(s): Device
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic