GRAMPUS-CF: Understanding gut symptoms in people with CF

Details

CTAP badge
Therapeutic approach
Nutritional-GI
Trial status
Open to recruitment Participating Centres
Trials Tracker ID
TT013986
Last updated
19/01/2024

Full title

A study to understand different patterns of gut symptoms in people with CF and what causes them

Study details

One of the top research priorities in the CF community is:

How can we relieve gastrointestinal (GI) symptoms such as stomach pain, bloating and nausea in people with CF?

To help answer this question, we need to understand the different patterns of symptoms that may occur in people with CF and what goes wrong in the body to cause these symptoms (we call this the ‘mechanism’). If we understand this correctly, we can choose treatments that are likely to help relieve symptoms and test these in clinical trials.

There will be two parts to the study: Part 1 and Part 2.

In this Part 1, researchers will observe diet and gut symptoms by asking you to complete questionnaires and give blood and stool (poo) samples at the beginning of the study, after 6 months, and after 12 months. They will use these to assess things like the gut microbiome (germs found in poo) and gut inflammation. Some people will also be asked to have a magnetic resonance imaging (MRI) scan of the abdomen. Part 1 has now concluded.

In Part 2, researchers will observe diet and gut symptoms by asking you to complete questionnaires at the beginning of the study, after 6 months, and after 12 months.

This study is being run by a Strategic Research Centre (SRC), funded by Cystic Fibrosis Trust, known as GRAMPUS-CF: Gut Research Advancing a Mechanistic and Personalised Understanding of Symptoms in Cystic Fibrosis.

Find out more about the GRAMPUS-CF SRC here.


Study updates

Remote participation:

Remote participation via app (12 years and older) is available. Please visit our webpage for instructions on how to take part: Join the study - take part in GRAMPUS-CF via the app — GRAMPUS-CF.

If you attend Nottingham or Leeds CF centres you may want to provide blood and poo samples or agree to an MRI scan in addition to remote participation.


Phase
Not applicable
Length of participation
12 months
Recruitment target
350
CF sponsor
The University of Nottingham
CF sponsor type
Academic

Who can take part?

Age range
Aged 6 years and older
Including people
  • People with confirmed cystic fibrosis aged 6 years and older attending Nottingham and Leeds adult and children's CF Centres
  • Remote participation via app is available for people with CF aged 12 years and older attending any CF clinic. Please visit our webpage for instructions on how to take part: Join the study - take part in GRAMPUS-CF via the app — GRAMPUS-CF

Excluding people
  • With a diagnosis of an additional gastrointestinal condition e.g. inflammatory bowel disease, coeliac disease, or gastrointestinal cancer
  • Who are pregnant
Remote participation
Remote participation is possible for this trial
Get in touch

CF centres running this trial

Closed

Nottingham Children's Hospital (Paediatrics)

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Address
Queen's Medical Centre
Derby Road
NG7 2UH
Recruitment starts
Recruitment ends
Trial Coordinators
Christina Francis
Closed

Nottingham City Hospital (Adults)

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Address
City Hospital, Wolfson Cystic Fibrosis Centre
Hucknall Road
NG5 1PB
Recruitment starts
Recruitment ends
Trial Coordinators
Fozia Naushahi
Closed

St James's University Hospital - Leeds (Adults)

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
St James's University Hospital
Beckett Street
LS9 7TF
Recruitment starts
Recruitment ends
Trial Coordinators
Helen Chadwick