EARLY-CF
Research type
Research Study
Full title
EARLY-CF: Exploring the impact of Antibiotics and the Response to modulator therapies within the gut microbiome in early Life and Young people with Cystic Fibrosis
IRAS ID
355290
Contact name
Chris van der Gast
Contact email
Sponsor organisation
University of Northumbria at Newcastle
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Cystic fibrosis (CF) is a genetic condition that affects the whole body, caused by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) protein, causing it to malfunction. This leads to thick, sticky mucus building up around the body, especially the lungs and digestive system. People with CF experience progressive lung damage and gastrointestinal (GI) problems, such as difficulty digesting food, bloating, stomach pain, and blockages in the intestines.
The introduction of CFTR modulators has improved outcomes in people with CF by restoring function to the defective CFTR protein. CFTR modulators address the underlying cause of CF, while previous treatments only managed the symptoms. However, GI problems can persist in some individuals with CF, with around two-thirds of people with CF missing school or work due to GI problems. Treating GI problems is a top research goal of The Cystic Fibrosis Trust and James Lind Alliance refresh of the top 10 research priorities in cystic fibrosis (2023), with the research question: “How can we relieve gastro-intestinal symptoms, such as stomach pain, bloating and nausea”.
Recent studies show that the microbes living in the gut play an important role in health and disease. In people with CF, the gut microbiome (the community of microbes in the gut) is significantly different from that of healthy individuals, which is thought to contribute to inflammation and increased risk of GI-related cancers in people with CF. Antibiotics are often used to treat lung infections in people with CF but are thought to disrupt the gut microbiome, although this has not yet been characterised.
This study will investigate how perturbations commonly experienced by individuals with CF impact the gut microbiome. Both stool and respiratory samples will be collected for microbiota analysis. The stool samples will be used to establish a gut model, for further experiments.
REC name
London - Hampstead Research Ethics Committee
REC reference
25/PR/0892
Date of REC Opinion
13 Aug 2025
REC opinion
Further Information Favourable Opinion