RecruitingNAINTERVENTIONAL

Biologics and Partial Enteral Nutrition Study

Crohn's disease can be tough, causing tummy pain and other problems. While injections (called biologics) and a special milkshake diet are common treatments, biologics don't work for everyone, and sticking to just milkshakes for weeks is hard for adults. This study wants to see if replacing half an adult’s normal diet with these nutritious milkshakes can improve how well their biologic medicine works. Researchers will compare people who add milkshakes to their diet with those who continue eating as usual, tracking how they feel and how their disease markers change over time. They'll also look at how this diet affects their overall health and quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

Start

20 Sep 2021

Estimated completion

01 Sep 2026

Crohn Disease

What is this study about?

Crohn's disease is a long-lasting condition that causes irritation and swelling in your gut. This can lead to symptoms like diarrhoea, severe belly pain, and trouble getting enough nutrients from your food, which can really affect your daily life. While we don't have a cure yet, some treatments can help manage it.

Two main ways doctors treat Crohn's are with special injections or infusions, called biologics, or by prescribing a liquid-only diet using special milkshakes. Biologics work for some people, but not everyone. The milkshake diet can be very effective and safe, but it's really hard for adults to stick to only milkshakes for several weeks because they can't eat any solid food. This makes it difficult to follow for the full time needed.

This study, called BIOPIC, is looking into a new idea for adults with Crohn's. The researchers want to find out if replacing just half of your usual meals with these nutritious milkshakes could help your biologic medicine work better. They will compare two groups: one that has half their food replaced by milkshakes, and another that eats normally. They will then check for improvements in symptoms and other disease signs, and see how people feel in terms of their overall health and quality of life for up to a year. They'll also explore how these dietary changes might affect the helpful bacteria in your gut.

Key takeaways

Exploring if partial milkshake diet helps biologic medicine work better for Crohn's.
For adults with active Crohn's starting adalimumab for the first time.
Compares adding milkshakes to half your diet vs. usual diet for 6 weeks.
Follow-up for improvements in symptoms, quality of life, and gut health for up to a year.
Potential to find a more effective way to manage Crohn's disease.

Who may be eligible?

This study is looking for adults aged 16 or over who have active Crohn's disease and are about to start a specific biological injection called adalimumab for the very first time. You must be able to understand the study and agree to take part in writing.

There are several reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, have had certain surgeries like a stoma, or have had a short bowel, you wouldn't be able to participate. Also, if you’re currently taking other new or experimental medications for Crohn's, or certain high doses of steroids, or if your gut disease involves specific severe issues like major fistulas (abnormal connections) or very narrow sections of the bowel, you would be excluded.

Other reasons for not being able to join include if you have certain infections like HIV, Hepatitis, or untreated tuberculosis, or if you have food allergies (like to cow's milk) that would prevent you from having the special milkshakes. If you've been included in other drug trials or dietary studies recently, that would also mean you can't join this one.

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.

Are you 16 years old or older?
Do you have active Crohn's disease?
Are you about to start adalimumab injections for the first time?
Are you not pregnant or breastfeeding?
Do you have any severe food allergies (e.g., cow's milk) that would stop you drinking the milkshakes?
Have you *not* had other similar experimental treatments or diets recently?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve roughly 80 adult patients. You will be randomly put into one of two groups. For 6 weeks, one group will replace half of their usual meals with special, nutritious milkshakes, while the other group will continue eating their normal diet. You will continue to receive your new biologic injections (adalimumab) as part of your standard care. The researchers will check on your symptoms and disease markers at 6 weeks and 12 weeks. They will also follow up for up to a year to see if you remain symptom-free. Throughout the study, they will also look at how your nutrition and quality of life are affected, and potentially collect samples to study your gut bacteria. The total duration of active dietary intervention is 6 weeks, with checks and follow-ups extending up to a year.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that adding special milkshakes might help your new biologic medicine work better in managing your Crohn's disease and improving your symptoms. However, it's also possible that this approach might not work for you, or it could be challenging to stick to the partial milkshake diet. The risks are thought to be low, as the milkshakes are nutritionally complete, but there might be side effects from the biologics you're taking, which are part of your standard treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Glasgow Royal Infirmary
Verified postcode
Glasgow, United Kingdom· Recruiting
Queen Elizabeth University Hospital
Verified postcode
Glasgow, United Kingdom· Recruiting
Gartnavel General Hospital
Verified postcode
Glasgow, United Kingdom· Recruiting
The New Victoria Hospital
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What exactly are these 'special milkshakes'?

They are specially designed, nutritionally complete liquid drinks, similar to those used in other diets for Crohn's, to ensure you get all the nutrients you need.

Will I still be able to eat some normal food?

Yes, if you're in the milkshake group, you will replace only half of your usual meals with the milkshakes, meaning you can still eat solid food for the other half.

How long will I be involved in the study?

The special diet part will last for 6 weeks, but researchers will check on you for up to a year to see how you are doing.

What is 'adalimumab'?

Adalimumab is a common type of biologic medicine, given by injection, that helps reduce inflammation in the gut for people with Crohn's disease.

What happens if I don't feel well during the study?

Your safety and well-being are a priority. You will be monitored, and you can discuss any concerns with the study team at any time and withdraw if needed.

How to find out more

Aleksandra Jatkowska, BSc (Hons)

a.jatkowska.1@research.gla.ac.uk 07743585420 Official trial record

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