RecruitingOBSERVATIONAL

Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)

This study is developing a new and easy-to-use questionnaire, called the CFAbd-Score, to help people with Cystic Fibrosis (CF) describe the problems they experience with their stomach and gut. People with CF often have tummy pain, bloating, and digestion issues. Because these can significantly impact daily life, understanding them better is very important. This new tool will involve input from patients, families, and healthcare professionals. Researchers will check if it reliably captures abdominal symptoms across different age groups, from young children to adults. They also want to see if the questionnaire can be used in other clinics and countries. The goal is to provide a clear way for patients to explain their symptoms, helping doctors give more tailored and effective care.

At a glance

Status

Recruiting

Sponsor

Medizinische Hochschule Brandenburg Theodor Fontane

Enrolment target

2,000

Start

26 Jan 2017

Estimated completion

31 Dec 2027

Cystic Fibrosis

What is this study about?

This study is all about creating a better way to understand and measure the stomach and gut problems that people with Cystic Fibrosis (CF) often experience. Many people with CF have issues like tummy pain, bloating, and digestion difficulties, which can really affect their daily life and wellbeing. Currently, there isn't one simple, clear tool that doctors and patients can use to easily describe and keep track of these problems. This new tool, called the CFAbd-Score, aims to change that.

The researchers are developing a special questionnaire that patients can fill out themselves. They want to make sure it's easy to understand and use, and that it accurately captures all the different tummy troubles associated with CF. They will be asking CF patients, their families, and healthcare professionals for their thoughts and ideas to ensure the questionnaire is helpful and relevant. They're also creating versions for daily use (CFAbd-day2day) and for children under 12 (CFAbd-kid).

The main goal is to create a reliable and helpful tool that can be used in clinics here in the UK and even adapted for use in other countries and languages. By having a clearer picture of how CF affects the stomach and gut, doctors can better understand each patient's symptoms and provide more personalised and effective ways to manage their care. This could lead to better quality of life for people with CF.

Key takeaways

Developing a new questionnaire (CFAbd-Score) for tummy problems in CF.
Aims to improve how doctors understand and treat CF gut symptoms.
Involves completing surveys, not taking new medicines.
Open to people of all ages with CF and healthy volunteers.
Participation could help improve care for people with CF worldwide.

Who may be eligible?

To take part in the main part of the study for people with Cystic Fibrosis, you would need to have received a diagnosis of CF. This diagnosis is usually confirmed by a sweat chloride test result higher than 60, or by having two known CF gene changes (mutations) and showing signs of CF affecting your body.

There's also a part of the study that needs healthy volunteers. If you're healthy and match the age of someone participating with CF, you might be able to join this group. The researchers will make sure you don't have other health conditions that could cause tummy problems, like inflammatory bowel disease or food allergies.

However, if you or your family aren't able to understand and work with the study team, you wouldn't be able to join the CF group. Also, if you're a healthy volunteer and have any other conditions that cause tummy issues, you wouldn't be eligible for that part of the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of Cystic Fibrosis?
Am I able to understand and cooperate with the study instructions (or can my family help me)?
If I am a healthy person, do I already have other tummy problems like Crohn's disease or food allergies?
Am I willing to fill out questionnaires about my digestion?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you would do is complete a new questionnaire about your stomach and gut symptoms. The researchers will ask you to fill out this questionnaire a few times to check if your answers are consistent and if the tool works well over time. They might also ask you to complete a daily diary about your symptoms for a period.

For some parts of the study, you might be asked to provide a stool sample to check for markers of inflammation in your gut. The study aims to be as convenient as possible, focusing mainly on questionnaire completion. The total duration of your participation would depend on which specific parts of the study you are involved in, but the main focus is on gathering information through these questionnaires over time.

Potential risks and benefits

Taking part in this study doesn't involve any medical treatments or medicines, so there are very few direct risks. You might find completing the questionnaires takes a little time and effort, and you might discuss your symptoms, which could occasionally be uncomfortable. However, there are no physical risks. A potential benefit is that by sharing your experiences, you'll be helping to develop a tool that could greatly improve how stomach and gut problems in CF are understood and managed in the future, for both yourself and other patients. Remember, you can choose to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Klinikum Westbrandenburg
Verified postcode
Brandenburg an der Havel, Germany· Recruiting
Medizinische Hochschule Brandenburg (MHB), University
Verified postcode
Brandenburg an der Havel, Germany· Recruiting

Common questions

What is the main purpose of this study?

The main purpose is to create a new questionnaire to help people with Cystic Fibrosis better describe their stomach and gut problems.

Will I have to take any new medicines?

No, this study does not involve taking any new medicines or treatments.

Who can take part in this study?

People of all ages with a confirmed diagnosis of Cystic Fibrosis, and healthy volunteers of matching ages, might be able to take part.

What will I have to do if I join the study?

You will mostly be asked to complete questionnaires about your stomach and gut symptoms, potentially a few times and possibly a daily diary.

Will my regular CF care change?

No, taking part in this study will not affect your usual Cystic Fibrosis medical care.

How to find out more

Jochen G Mainz, Prof. MD

jochen.mainz@mhb-fontane.de +493381411803 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.