ENTOPIC Trial virtual clinical study for children with functional abdominal pain disorder aged 3-18

Welcome to the ENTOPIC TRIAL

Join our virtual clinical trial for children aged 3-18 years with a Functional Abdominal Pain Disorder*

This study is testing the efficacy of ENTEROSGEL® to relieve abdominal pain in patients with a Functional Abdominal Pain Disorder. ENTEROSGEL® is a medical device available in retail stores and pharmacies and on prescription, it is used for all ages from newborns upwards. ENTEROSGEL®  is an intestinal adsorbent that is a tasteless gel you mix in water and take as a drink.  

⚛︎ Join from the comfort of your own home – all online

⚛︎ SIMPLE 2-minute daily online diary

⚛︎ Try a new treatment that could relieve tummy pain

⚛︎ Treatment delivered to your door

⚛︎ 10 week trial – everyone tries ENTEROSGEL®

*includes: Functional Dyspepsia, IBS, Abdominal Migraine & Functional Abdominal Pain Not Otherwise Specified

Frequently asked questions

What are the ingredients of How ENTEROSGEL®?

ENTEROSGEL® is not a drug, it is made from an organic mineral and water only (70% polymethylsiloxane and 30% purified water).

What is ENTEROSGEL® used to treat?

ENTEROSGEL® can treat acute (short-term) diarrhoea and irritable bowel syndrome with diarrhoea (IBS-D).

Acute diarrhoea includes gastroenteritis (tummy bugs), food poisoning, traveller’s diarrhoea, food allergies/intolerances, stress or hormone related diarrhoea. ENTEROSGEL® reduces the duration that the diarrhoea lasts and reduces the frequency of loose stools.

Irritable bowel syndrome with diarrhoea, has regular diarrhoea and other symptoms. ENTEROSGEL® relieves diarrhoea, abdominal pain, bloating, and urgency and also improves quality of life in people with IBS-D.

How do I take my treatment?

⚛︎ Shake the tube well before opening and measure the contents into a measuring cup (double-blind phase) or measuring spoon (open-label phase). Add room temperature water and drink immediately.

⚛︎ Leave 2 hours before and after taking your treatment and taking any other medication, or 1-2 hours for eating meals

⚛︎ Read your “Treatment Use Instructions” to make sure you are using the treatment as recommended

When do I take my treatment?

It is best to take the treatment evenly during the day (morning and evening)

Can I mix the treatment in dilute juice?

It is best to take the treatment in water, but you can mix in dilute juice if you prefer

What do I do if I miss a treatment?

Do not worry if you miss a dose. Just continue taking it according to the “Treatment Use Instructions”.

Who do I contact if I am running out of treatment?

You have been given enough treatment but contact your research nurse or doctor if there are any problems.

What are the possible side effects of the treatment?

The possible side effects include constipation and nausea, but these are mild and not common.

What do I do if I get constipation?

Wait until your next bowel movement and drink more water before taking your next treatment dose.

Who do I contact if I have any questions about the study?

Contact the study doctor or research nurse, the telephone number can be found in your study pack.

Who do I do if I miss completing a diary?

⚛︎ Don’t worry on the following day your text/email diary reminder will contain a link to the previous days diary which you can complete.

⚛︎ If you are having problems with the online diary please contact your research nurse

Can the treatment be taken alongside other medications?

You should not use any probiotic supplements, strong opioids, other intestinal adsorbents (activated charcoal, kaoline, diosmectite) or slow-release medications during the trial (please check with your research nurse/doctor if unsure). You can take other oral medication, but you should leave 2 hours before and after taking your treatment and taking any other medication.

Why should I leave 2 hours before and after taking my treatment and taking any other medication, or 1-2 hours for eating meals?

ENTEROSGEL® is an intestinal adsorbent and it is possible that it could adsorb some medications or nutrients from the gut, by leaving the gap between taking the treatment and taking your medication or eating a meal, this will prevent any removal.

Is the treatment suitable for vegans and vegetarians?

Yes, the treatment and placebo does not contain any ingredients of animal origin or products produced from animals.

Is it safe to take the treatment if I have a food allergy?

ENTEROSGEL® or the placebo do not contain substances that can cause allergic reactions, they are free from preservatives, gluten, lactose, sugar, nuts, taste or colour.

Patient Information sheets

These contain all the information for patients about the study – there are children/young person information sheets and also one for parents.