N/A
N=25
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03566550 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Orocaecal Transit Time — 330; 210 minutes — p=0.04
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- MRI scans (Diagnostic_test)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Nottingham University Hospitals NHS Trust
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Orocaecal Transit Time |
330; 210 | 0.04 sig |
| SECONDARY Gastric Half Emptying Times |
97; 80 | 0.3 |
| SECONDARY Small Bowel Water Content (Corrected for Body Surface Area) |
62; 34 | 0.021 sig |
| SECONDARY Colonic Volume (Corrected for Body Surface Area) |
186; 123 | 0.012 sig |
| SECONDARY Gastrointestinal Symptoms |
16; 7 | 0.13 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria:• Measurement of Forced Expiratory Volume in 1 second (FEV1) of 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
Data sourced from ClinicalTrials.gov (NCT03566550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.