RecruitingPhase II/IIIInterventional

Enterosgel® in the treatment of functional abdominal pain in children and young people

This study is exploring a treatment called Enterosgel for children and young people aged 3 to 18 who suffer from long-term tummy pain. This type of pain is often called Functional Abdominal Pain Disorder, which includes conditions like irritable bowel syndrome and abdominal migraine. These conditions can be difficult to manage, and the main goal is to reduce symptoms and improve quality of life. Enterosgel is a special gel that helps remove harmful substances from the gut. It's already used for conditions like diarrhoea. This study will see if it can also help reduce tummy pain and make a difference to how children feel day-to-day. Over 10 weeks, participants will either receive Enterosgel or a dummy treatment, then everyone will get Enterosgel to see if it helps.

At a glance

Status

Recruiting

Phase

Phase II/III

Sponsor

Enteromed Ltd

Enrolment target

154

Start

26 Mar 2026

Estimated completion

01 Dec 2026

Treatment of abdominal pain in children and young people with Functional abdominal pain disorders.

What is this study about?

This research study is about helping children and young people who experience ongoing tummy pain, specifically a group of conditions called Functional Abdominal Pain Disorders (FAPDs). You might have heard of some of these, like irritable bowel syndrome (IBS) or abdominal migraine. These conditions mean that despite looking healthy, there's a problem with how the gut works, causing uncomfortable symptoms like pain. There's no single cure for these types of pain, so doctors often focus on ways to manage the symptoms and improve a child's quality of life.

The study is investigating a product called Enterosgel. This is a special type of gel that you take by mouth. It works by acting like a sponge in your gut, soaking up certain harmful substances like toxins from bacteria. In the UK, Enterosgel is already used to treat short-term diarrhoea and IBS with diarrhoea in people of all ages. What's important is that it isn't absorbed into the body; it just passes through and is then expelled. Early research suggests that Enterosgel might help with tummy pain and diarrhoea in people with IBS. This new study wants to find out if it can do the same for children and young people with other FAPDs.

The main aim of this study, which will involve 154 children and young people between the ages of 3 and 18, is to see if Enterosgel can reduce their tummy pain and make their daily lives better. The researchers also want to make sure it's easy for children to take. The study will look closely at how much pain they experience and how it affects their quality of life before, during, and after taking Enterosgel. It's hoped that this research will provide clear answers on whether Enterosgel could be a helpful option for many children struggling with persistent tummy pain.

Key takeaways

Exploring Enterosgel for tummy pain in children aged 3-18.
Aims to reduce pain and improve daily life for Functional Abdominal Pain Disorders.
Enterosgel is a non-absorbed gel that helps remove harmful gut substances.
Study lasts 10 weeks, includes a phase where some get dummy treatment.
Low risk, potential benefit of pain relief but no guarantee.

Who may be eligible?

To join this study, children and young people need to be between 3 and 18 years old and have a doctor's diagnosis of a Functional Abdominal Pain Disorder. This means their tummy pain isn't caused by another serious gut condition, and tests like a specific stool test (faecal calprotectin) would have been within a normal range.

Participants also need to be able to complete questionnaires in English and use an online diary to record their symptoms. A parent or guardian will need to give their permission and help with reports, especially for younger children. The doctor running the study will also need to agree that the child is suitable to take part.

Some reasons why someone might not be able to join include having certain other gut conditions like coeliac disease or inflammatory bowel disease. If they are already regularly using certain medications like antidepressants (unless on a settled dose for a while), probiotics, or strong painkillers, they might also be excluded. Children who are pregnant or could become pregnant during the study would not 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 3 and 18 years old?
Do you have a diagnosis of Functional Abdominal Pain Disorder?
Have you had a normal faecal calprotectin test (a specific stool test) for your age when diagnosed?
Can you complete diaries and questionnaires online in English?
Do you *not* have coeliac disease or inflammatory bowel disease?
Are you *not* regularly using certain strong medications, probiotics, or other gut adsorbents?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for a total of 10 weeks. Here's a breakdown of what that involves:

* **First 2 weeks (Observational Phase):** You won't take any study medicine yet. Your job will be to keep an online diary about your tummy pain and other symptoms. This helps the researchers understand your usual symptoms before any treatment starts. * **Next 4 weeks (Treatment Phase):** This is where you will take either Enterosgel or a dummy treatment (called a placebo). Neither you nor the study team will know which one you are getting. You'll continue to record your symptoms in your online diary. * **Final 4 weeks (Open-Label Phase):** During this period, everyone taking part will receive Enterosgel. Again, you'll track your symptoms in your diary.

Throughout the study, you'll be asked to complete online questionnaires about your symptoms and how you're feeling. There won't be many hospital visits, as much of the data collection is done through the online diary and questionnaires at home. This study is designed to be as convenient as possible while gathering important information.

Potential risks and benefits

Taking part in this study could potentially offer benefits, as Enterosgel might help to ease your tummy pain and improve your overall quality of life. The product has already been shown to be safe and effective for similar conditions and age groups, meaning the risks in this study are considered very low. Enterosgel is not absorbed by the body, so it doesn't generally cause serious side effects like medicines can. As with any study, you are free to leave at any time, for any reason, without it affecting your medical care.

Locations (2)

Alder Hey Children's NHS Foundation Trust
City only
Liverpool,, England
Bristol Royal Hospital for Children
Approximate
Bristol, England

Common questions

What is Enterosgel?

Enterosgel is a special gel you take by mouth. It helps remove harmful substances from your gut without being absorbed into your body.

What are Functional Abdominal Pain Disorders?

These are long-term tummy pains like irritable bowel syndrome or abdominal migraine, where the gut isn't working quite right, but there's no serious underlying disease.

Will I know if I'm getting Enterosgel or a dummy treatment?

For the first part of the treatment, neither you nor the study team will know. This is called 'double-blind' to make the results fair.

How long does the study last?

The study lasts for 10 weeks in total, with different phases of observation and treatment.

Which hospitals are running this study?

The study is being run from Alder Hey Children's NHS Foundation Trust and Bristol Royal Hospital for Children in the UK.

How to find out more

Carol Howell

research@enteromed.co.uk 447596887046 Official trial record

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