Gut Imaging for Function & Transit in Cystic Fibrosis Study 1

NCT03566550 | Completed Results

• 1 other identifier: 18GA006
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Orocaecal Transit Time

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

  1 day of scanning

Secondary Outcomes (4)

• Gastric Half Emptying Times

  1 day of scanning

• Small Bowel Water Content (Corrected for Body Surface Area)

  1 day of scanning

• Colonic Volume (Corrected for Body Surface Area)

  1 day of scanning

• Gastrointestinal Symptoms

  1 day of scanning

Other Outcomes (2)

• T1 Relaxation Time of Ascending Colon Chyme

  1 day of scanning

• Fat Fraction of the Ascending Colon Chyme

  1 day of scanning

Study Arms (2)

CF

people with cystic fibrosis

Diagnostic Test: MRI scans

Control

people without cystic fibrosis

Diagnostic Test: MRI scans

Interventions

MRI scans DIAGNOSTIC_TEST

Repeated MRI scans imaging digestion of standard meals

CF; Control

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Nottingham and surrounding towns

You may qualify if:

• Age 12 - 40 years
• Capacity to consent, or to understand the requirements of the study where parental consent is needed
• PATIENTS: confirmed diagnosis of Cystic Fibrosis, either by sweat test or genetic testing; to reduce heterogeneity, we will only enrol homozygous CF patients with the most common CFTR mutation, p.Phe508del
• CONTROLS: no clinical evidence or suspicion of Cystic Fibrosis

You may not qualify if:

• Contra-indication to MRI scanning, such as embedded metal, pacemaker
• Unable to stop medications directly prescribed to alter bowel habit, such as laxatives of anti-diarrhoeals, on the study day
• Previous resection of any part of the gastro-intestinal tract apart from appendicectomy or cholecystectomy. Surgical relief of distal ileal obstruction syndrome or neonatal ileus will be permitted unless clinical records show excision of intestine \>20cm in length.
• Intestinal stoma
• Diagnosis of inflammatory bowel disease or coeliac disease confirmed by biopsy
• Gastrointestinal malignancy
• Unable to comply with dietary restrictions required for the study

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals National Health Service Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Professor Alan Smyth
• Organization: University of Nottingham

alan.smyth@nottingham.ac.uk

01158230612

Study Officials

• Alan Smyth, Prof

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: September 4, 2018
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: July 21, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)