Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study
Crohn's disease is a long-term condition causing gut inflammation. Two common treatments are biologic injections and a liquid-only diet of special milkshakes. While biologics work for some, and the liquid diet is safe and effective, it's hard to follow and doesn't always stop symptoms from returning after eating solid food again. This study, BIOPIC-Kids, will explore if replacing some or all of a child's normal diet with these special milkshakes for six weeks improves how well biologic treatments work and helps children stay in remission. Children and young people aged 6-18 starting biologics for Crohn's can join. They'll either stick to their usual diet or replace some of it with milkshakes. We're also studying those already on these treatments to compare results.
At a glance
What is this study about?
Crohn's disease is a condition that causes inflammation in your gut, which can lead to symptoms like tummy pain, diarrhoea, and tiredness. Currently, there's no cure, but there are treatments to help manage it. Two important approaches are special injected medicines called 'biologics' and a liquid-only diet using special milkshakes. While biologics can be very helpful for some, they don't work for everyone. The liquid-only diet is known to be safer and quite effective, especially for children. However, it can be really difficult for children and young people to stick to for six to eight weeks, and symptoms sometimes come back once they start eating normal food again.
This study, called BIOPIC-Kids, wants to find out if using these special milkshakes for six weeks while starting new biologic medicines can help children and young people with Crohn's disease. We're hoping it might make the biologic treatment work better, help them feel better faster, and keep their symptoms away for longer. We'll be looking at children and young people between 6 and 18 years old who are about to start biologics for their Crohn's disease as part of their usual care.
Participants will either continue eating their normal diet or replace different amounts of their normal food with these special milkshakes for six weeks. Some patients might even be able to choose which group they'd prefer to be in. We'll also be looking at what happens to children who are already using a liquid-only diet, or a liquid diet alongside biologics, to understand the different outcomes of these treatments. The study will mainly compare how many patients improve after about 10-12 weeks and how many stay symptom-free for up to a year. We'll also see how the liquid diet affects their nutrition, body shape, and general quality of life.
Key takeaways
- Exploring if specific milkshakes aid biologic treatment in children with Crohn's.
- Ages 6-18, already starting biologic injections for Crohn's.
- Comparing a normal diet vs. a diet with some special milkshakes for 6 weeks.
- Measuring how well treatments work and how long patients stay well.
- Looks at nutrition, body shape, and quality of life too.
- Participation lasts about one year with clinic visits.
Who may be eligible?
This study is looking for children and young people aged between 6 and 18 years old who have active Crohn's disease. To be considered, your child needs to be about to start a new biologic medicine called infliximab or adalimumab as part of their usual treatment plan. We are also interested in hearing from children and young people in the same age group who are about to start a liquid-only diet (with or without these biologic medicines).
There are some reasons why your child might not be able to join the study. For example, if they have certain bowel problems like a stoma or short bowel syndrome, or if they are currently taking high doses of steroids. Children who have severe forms of Crohn's, other serious infections, or specific eating disorders like anorexia nervosa would also not be able to take part. It's also important that your child (if they are 16-18) or you (as their parent/carer for younger children) are able to understand and agree to take part.
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.
- Is your child aged between 6 and 18 years old?
- Does your child have active Crohn's disease?
- Is your child about to start new biologic injections (infliximab or adalimumab)?
- Are you able to agree to your child taking part in the study?
- Does your child NOT have a stoma or short bowel syndrome?
- Is your child NOT currently taking high doses of steroid medication?
What does participation involve?
If you or your child decides to take part, you'll be joining one of two main groups for six weeks. One group will continue to eat their normal diet, while the other group will replace varying amounts of their normal food with special liquid milkshakes. You might even be able to choose which group you'd prefer to be in.
Throughout the study, there will be a series of appointments to check on progress. This typically involves visits to the clinic over a year, where healthcare professionals will carry out assessments. These assessments will involve checking symptoms, taking blood or stool samples to measure inflammation levels, and discussing how you or your child are feeling. We'll also look at nutrition, body composition, and quality of life through questionnaires. The total duration of active follow-up for the study will be approximately one year.
Potential risks and benefits
Locations (6)
- The Royal Aberdeen Children's HospitalVerified postcodeAberdeen, United Kingdom· Not yet recruiting
- University Hospital CrosshouseVerified postcodeCrosshouse, United Kingdom· Not yet recruiting
- Ninewells HospitalVerified postcodeDundee, United Kingdom· Not yet recruiting
- Royal Hospital for Children & Young PeopleVerified postcodeEdinburgh, United Kingdom· Recruiting
- Royal Hospital For ChildrenVerified postcodeGlasgow, United Kingdom· Recruiting
- University Hospital WishawVerified postcodeWishaw, United Kingdom· Not yet recruiting
Common questions
What is a 'biologic' medicine?
Biologics are special medications given by injection that target specific parts of the immune system to reduce inflammation in Crohn's disease.
What is a 'liquid-only diet'?
It means getting all your nutrition from special liquid milkshakes for a period, instead of solid food. It's a proven way to help the gut heal in Crohn's.
Will my child have to exclusively drink milkshakes?
Not necessarily. Some participants will keep their normal diet, while others will replace varying amounts of their usual food with the special milkshakes for 6 weeks.
How long will the study last?
The main part of the study involves following a specific diet for 6 weeks, with follow-up appointments and monitoring continuing for up to a year.
Can I choose which treatment group my child is in?
Yes, some participants may be able to choose which group they prefer, rather than being randomly allocated.
How to find out more
Konstantinos Gerasimidis, Professor
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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