Trial Outcomes & Findings for Gut Imaging for Function & Transit in Cystic Fibrosis Study 1 (NCT NCT03566550)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

1 day of scanning

Results posted on

2021-07-21

Participant Flow

51 CF patients were eligible. CF patients were approached in order of their hospital attendance and the first 12 to provide written consent were enroled into the study. 13 declined to participate and 2 withdrew consent as they did not like the standardised meals or MRI. 12 CF patients and 12 controls completed the protocol without any adverse events. 1 further control was withdrawn and replaced as the participant was unable to complete the first standardised meal and the remaining 10 MRI scans.

Participant milestones

Participant milestones
Measure	Cystic Fibrosis people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Overall Study STARTED	12	13
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cystic Fibrosis people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cystic Fibrosis n=12 Participants people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control n=12 Participants people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=12 Participants	5 Participants n=12 Participants	10 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=12 Participants	7 Participants n=12 Participants	14 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=24 Participants
Sex: Female, Male Female	5 Participants n=12 Participants	5 Participants n=12 Participants	10 Participants n=24 Participants
Sex: Female, Male Male	7 Participants n=12 Participants	7 Participants n=12 Participants	14 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	12 participants n=12 Participants	12 participants n=12 Participants	24 participants n=24 Participants
Weight (kg)	56 kg n=12 Participants	62 kg n=12 Participants	59 kg n=24 Participants
Height (cm)	166 cm n=12 Participants	166 cm n=12 Participants	166 cm n=24 Participants

PRIMARY outcome

Timeframe: 1 day of scanning

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

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=12 Participants people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control n=12 Participants people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Orocaecal Transit Time	330 minutes Interval 270.0 to please note the upper quartile for the cystic fibrosis group states NA due to censored data after 360 minutes (MRI scans were only performed until 360 minutes).	210 minutes Interval 173.0 to 315.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=12 Participants people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control n=12 Participants people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Gastric Half Emptying Times	97 minutes Interval 71.0 to 128.0	80 minutes Interval 66.0 to 88.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=12 Participants people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control n=12 Participants people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Small Bowel Water Content (Corrected for Body Surface Area)	62 L.min/m^2 Interval 36.0 to 80.0	34 L.min/m^2 Interval 28.0 to 41.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=12 Participants people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control n=12 Participants people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Colonic Volume (Corrected for Body Surface Area)	186 L.min/m^2 Interval 166.0 to 206.0	123 L.min/m^2 Interval 89.0 to 146.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cystic Fibrosis n=12 Participants people with cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals	Control n=12 Participants people without cystic fibrosis MRI scans: Repeated MRI scans imaging digestion of standard meals
Gastrointestinal Symptoms	16 CFAbd-Score units Interval 5.0 to 25.0	7 CFAbd-Score units Interval 3.0 to 14.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day of scanning

An approximate measure of water content in chyme present in the ascending colon

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day of scanning

A measure of fat content in chyme present in the ascending colon

Outcome measures

Outcome data not reported

Adverse Events

Cystic Fibrosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Alan Smyth

University of Nottingham

Phone: 01158230612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place