Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Many people with Cystic Fibrosis (CF) are troubled by symptoms from their stomach and bowels:
      their gastrointestinal (GI) tract. Symptoms affect quality of life and can also reduce
      people's ability to digest enough calories to remain healthy, leaving them undernourished and
      less able to deal with other health problems such as infection.

      Clinical tests to assess bowel function are limited. Many tests involve inserting a sensor or
      camera into the bowel, so they are not suitable for long periods, and can be uncomfortable.
      In Nottingham the investigators have developed imaging scans which can assess how someone's
      digestion works without any invasive device. The type of scanning the investigators use is
      called Magnetic Resonance Imaging, or MRI.

      The purpose of this study is to see if those scanning methods can be used in people with CF
      to understand their digestion and any problems they have.
    

Detailed description: 
      This is a small pilot study to establish that differences in digestion between people with
      and without CF can be quantified by repeated MR scans in fasted participants in response to
      standardised meals.

      Participants will complete questionnaires on gastrointestinal function and symptoms: the
      PAC-SYM questionnaire, validated to assess symptom burden in adults with chronic
      constipation; and the CF abdomen questionnaire, developed in German for use in young people
      and adults with cystic fibrosis.

      After this, participants only need to attend one study day at the Sir Peter Mansfield Imaging
      Centre. On this day they will be asked to withhold any medicines specifically targeted to
      alter bowel habit. This shall include laxatives but not enzyme replacement therapy. They
      should attend on the study day having fasted since waking, other than water for essential
      medicines.

      They will have their first MRI scan fasted. After the scan they will eat a standard test
      meal, and be scanned again first at half hour, then hour intervals until six hours after the
      first meal. The final scan will constitute the end of the study for each participant. Each
      session in the MRI scanner will last around 15 minutes. After each scan they will complete a
      validated rating scale for any current symptoms: the Gastrointestinal Symptom Rating Scale
      (GSRS).In between scans, participants will have access to a lounge with wifi and a
      television.

      Infection control requirements mean that the investigators are unable to scan more than one
      patient with CF on a single day. Patient scans will alternate with those of a Control
      participant. The investigators will aim to frequency match Controls with Patients for age and
      gender.
    

Intervention name(s): MRI scans
Intervention type(s): Diagnostic Test
Intervention description(s): Repeated MRI scans imaging digestion of standard meals
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Nottingham and surrounding towns