RecruitingNAINTERVENTIONAL

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

This study, called RE-EEN, is for children and young people aged 8 to 21 who have recently been diagnosed with Crohn's disease. We want to find out if using a special diet, called Exclusive Enteral Nutrition (EEN), can help manage their condition. We are comparing two types of EEN: a standard liquid formula and a new smoothie made from real foods. Participants will receive either the formula or guidance, a recipe, a blender, and food ingredients for the smoothie. The study lasts for 8 weeks and will assess how well participants tolerate the diet, how effective it is in reducing symptoms, changes in their gut bacteria, and their overall quality of life. The goal is to see which approach is more effective and easier for patients to manage.

At a glance

Status

Recruiting

Phase

Sponsor

Seattle Children's Hospital

Enrolment target

Start

11 Mar 2024

Estimated completion

10 Jan 2030

Crohn Disease

What is this study about?

This study is about a way of treating Crohn’s disease called Exclusive Enteral Nutrition, or EEN. This involves eating a special diet that provides all your body’s nutritional needs. It's often used in children and young people with Crohn's disease to help reduce inflammation and improve symptoms without needing medicines like steroids right away.

In this study, we want to compare two different ways of doing EEN. One way uses a special liquid formula that contains all the nutrients. The other way uses a smoothie made from real, whole foods that you blend at home. We want to see which one works better for young people with newly diagnosed Crohn's disease, and which one they find easier to stick to.

By comparing these two approaches, we hope to find out if a whole-food smoothie can be just as good, or even better, than the standard formula for helping people manage their Crohn's disease. We'll be looking at things like how well people tolerate the diet, if their symptoms improve, changes in their gut health, and how their daily life is affected over 8 weeks.

Key takeaways

This study compares two special diets (EEN) for young people with new Crohn's disease.
It’s comparing a liquid formula with a whole-food smoothie diet.
The study lasts 8 weeks and aims to see which diet is more effective and easier to follow.
Participants will get all necessary food, recipes, and equipment for their diet.
It will assess diet tolerance, symptom improvement, and gut health.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is looking for young people aged between 8 and 21 years old who have been diagnosed with Crohn's disease in the last two years. To join, you should have active Crohn's disease, meaning your doctor can see signs of inflammation, for example, through blood tests or stool tests.

There are also some reasons why you might not be able to join. For example, if you've had surgery for your Crohn's, if you have a specific type of Crohn's called perianal disease, or if you've recently taken certain medications like steroids or changed the dose of other Crohn's medicines. Also, if you’ve tried EEN or other dietary treatments for Crohn’s before, or have a known allergy to any ingredients in the smoothie, you wouldn't be able to participate.

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 between 8 and 21 years old?
Were you diagnosed with Crohn's disease in the last 2 years?
Does your doctor say your Crohn's disease is currently active?
Have you NOT had surgery for your Crohn's disease?
Have you NOT taken certain medications (like steroids) recently?
Are you able to give permission, or can your parent/guardian give permission, to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a total of 8 weeks. You will be randomly placed into one of two groups. One group will follow a special liquid diet using a commercial formula, and the other group will follow a special smoothie diet made from whole foods. If you're in the smoothie group, we will give you a specific recipe, a blender, and the food ingredients you'll need to make your smoothies at home.

During the 8 weeks, the study team will regularly check in with you to see how you are getting on. They will assess how well you tolerate the diet (meaning if you have any side effects or find it difficult), how your Crohn's symptoms are changing, and collect samples (like stool samples) to look at your gut bacteria. We will also ask you questions about your quality of life to understand how the diet is affecting you day-to-day. You will have regular contact with the study team throughout this period.

Potential risks and benefits

Taking part in any study has possible benefits and risks. A potential benefit of this study is that one of the EEN diets might help to reduce your Crohn's symptoms and inflammation. You will also be closely monitored by medical professionals. Potential risks might include finding the diet challenging to stick to, or experiencing some mild side effects from the diet, though the research team will support you throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Children's Hospital of Philadelphia
Verified postcode
Philadelphia, United States· Not yet recruiting
Seattle Children's Hospital
Verified postcode
Seattle, United States· Recruiting
Izaak Walton Killam Health Centre
Verified postcode
Halifax, Canada· Not yet recruiting

Common questions

What is EEN?

EEN stands for Exclusive Enteral Nutrition. It's a special diet that provides all your body's food and nutrients, usually in liquid form, to help reduce inflammation in Crohn's disease.

What will I have to eat on the study?

You'll either have a special liquid formula or a smoothie made from real foods, depending on which group you are in. The study team will provide all the details and support.

How long does the study last?

The study will last for 8 weeks in total.

Will I have to pay for the special food?

No, the study will provide you with either the commercial formula or the ingredients for the smoothie, along with a blender if you're in the smoothie group.

Can I stop the study if I want to?

Yes, you can choose to leave the study at any time, and it won't affect the care you receive from your doctor.

How to find out more

Mason E Nuding

mason.nuding@seattlechildrens.org 206-987-0055 Official trial record

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