NCT03566550: GIFT-CF1

Gut Imaging for Function & Transit in Cystic Fibrosis Study 1

Completed Results posted Last updated 21 July 2021

What this trial tests

trial testing MRI scans in Cystic Fibrosis in 25 participants. Completed in 20 February 2019.

Timeline

4 September 2018

Primary endpoint
20 February 2019

20 February 2019

Quick facts

Lead sponsor	Nottingham University Hospitals NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	25
Start date	4 September 2018
Primary completion	20 February 2019
Estimated completion	20 February 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• MRI scans

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Nottingham University Hospitals NHS Trust

Who can join

Adults 12 to 40, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Orocaecal Transit Time Primary · 1 day of scanning

time taken after eating for ingested food to be identifiable in the caecum on MRI

Group	Value	95% CI
Cystic Fibrosis	330	270 – NA
Control	210	173 – 315

Gastric Half Emptying Times Secondary · 1 day of scanning

volume of stomach at each time point of digestion to measure speed of gastric emptying (time taken for half the gastric contents to be emptied)

Group	Value	95% CI
Cystic Fibrosis	97	71 – 128
Control	80	66 – 88

Small Bowel Water Content (Corrected for Body Surface Area) Secondary · 1 day of scanning

volume of water content in small bowel representing secretions (area under the curve - timepoints at baseline then 0,30,60,90,120,150,180,240,300,360 minutes)

Group	Value	95% CI
Cystic Fibrosis	62	36 – 80
Control	34	28 – 41

Colonic Volume (Corrected for Body Surface Area) Secondary · 1 day of scanning

volume of colon representing ease of chyme passage through colon (area under the curve - timepoints at baseline then 0,30,60,90,120,150,180,240,300,360 minutes)

Group	Value	95% CI
Cystic Fibrosis	186	166 – 206
Control	123	89 – 146

Gastrointestinal Symptoms Secondary · 1 day of scanning

gastrointestinal symptoms as measured by questionnaires to monitor relationship with outcomes measured by MRI. Scale of the CFAbd-score ranges from 0-100. A low score indicates fewer gastrointestinal symptoms whilst a higher score indicates more severe and frequent gastrointestinal symptoms.

Group	Value	95% CI
Cystic Fibrosis	16	5 – 25
Control	7	3 – 14

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomised crossover trial of tezacaftor-ivacaftor for gut dysfunction in cystic fibrosis with magnetic resonance imaging (MRI) outcomes: a pilot study.
   Ng C, Dellschaft NS, Hoad C, Marciani L, et al · · 2023 · PMID 39139270 · DOI 10.3310/nihropenres.13510.2
2. Postprandial changes in gastrointestinal function and transit in cystic fibrosis assessed by magnetic resonance imaging
   Ng C, Dellschaft NS, Hoad CL, Marciani L, et al · · 2020 · DOI 10.1101/2020.02.19.20022020