ENTEROSGEL® Oral Intestinal Adsorbent

ENTEROSGEL® is a CE Certified medical device for oral administration, available over-the-counter and listed on the drug tariff in the UK for the symptomatic treatment of acute diarrhoea and treatment of irritable bowel syndrome with diarrhoea (IBS-D).

The active component of ENTEROSGEL® is an organosilicon compound; polymethylsiloxane polyhydrate, which is ingested as liquid gel and acts as an oral intestinal adsorbent.

It travels through GI tract adsorbing certain molecules, whilst neither being absorbed into the systemic circulation nor being metabolised, passing out of the gut unchanged (1). It has no pharmacological action.

You can access the technical datasheet using the link below:

Technical datasheet (PDF)

ENTEROSGEL® differs from other intestinal adsorbents in that it is relatively specific for adsorption of larger molecules such as proteins and bacterial toxins, and has a lower adsorption capacity for smaller molecules, e.g. vitamins, minerals and nutrients (1,2).

ENTEROSGEL® has a good safety profile with over 30 years of use, including safety to the gastrointestinal mucosa, high affinity elimination from the gastrointestinal system, and has convenient dosing with simple administration.

ENTEROSGEL®on Prescription

In this section you will find all the information you need as a clinician or pharmacist to prescribe and provide ENTEROSGEL® to your patient.

ENTEROSGEL® is listed by the NHS as a medical device that a GP can prescribe when suitable for the patient. ENTEROSGEL® is still a new medical device to many healthcare professionals. Even though there are many clinical studies including 2 published UK studies, some GPs may not have heard of ENTEROSGEL®, but many have been recommending ENTEROSGEL® to their patients to buy OTC for years already.

Now that ENTEROSGEL® is available on prescription, many patients with IBS-D and some with acute diarrhoea especially children and the elderly, would benefit from being able to try this effective treatment on prescription.

Some GPs prefer a treatment to be listed on their local formularies as well as the national Drug Tariff. We can provide the relevant effectiveness and cost/benefit data to you, so that you can apply to your local ICB formulary for inclusion of ENTEROSGEL®. (contact us at: research@enteromed.co.uk)

  • Listing details

    ENTEROSGEL® has been listed and can be found in several relevant databases for health professionals in the UK. It is listed on the platforms: EMIS and SystmOne.

  • BNF

    ENTEROSGEL® is not listed in the BNF at present. The BNF only provides information regarding medicines, not medical devices. 

    The absence of a product from the BNF does not preclude its prescription. Any product within the Drug Tariff can be prescribed on an NHS prescription unless it appears within Part XVIIIA of the Drug Tariff.

  • Dm+d

    ENTEROSGEL® is listed on the dm+d and is searchable on the following page:NHS dm+d browser

Drug tariff details

ENTEROSGEL® is listed in the Drug Tariff Part IX for England and Wales from 1st July 2023, and separately for Northern Ireland and for Scotland.

It can be found in the category ‘Appliances- Intestinal adsorbents’. The three versions of ENTEROSGEL® listed: 90g tube, 225 tube and 10x15g sachets.

For IBS-D the most cost-effective version to prescribe is the 225g tube. For acute diarrhoea in children the 90g tube is sufficient to treat one episode of diarrhoea.

Fulfilling a prescription

To fulfil an NHS prescription, ENTEROSGEL® may be ordered from our wholesalers:

  • Alliance in Healthcare
  • AAH
  • Sigma Pharmaceuticals
  • Lexon
  • Phoenix/Numark
  • Jumla
  • CLF

How Does ENTEROSGEL® Work?

The basis for ENTEROSGEL® use in IBS is not completely understood but is likely due to its capacity to adsorb endogenous and exogenous substances such as bacterial break-down products (e.g., lipopolysaccharides), bacterial toxins, immune chemicals and bile acids, thereby inactivating their effects whilst in the gut (2). The results of the recent large RCT (RELIEVE IBS-D) showed ENTEROSGEL is an all-in-one treatment for IBS with diarrhoea, and has been published in the leading international gastroenterology journal GUT (3). You can access the free article on our Research page of the menu.

In the large randomised clinical trial set in 28 GP and hospital sites in England and a “virtual site”, we recruited 440 patients with IBS-D. Patients received either ENTEROSGEL® or placebo for 8-weeks, then both groups received ENTEROSGEL for a further 8-weeks.

The study results showed that significantly more patients that took ENTEROSGEL® compared to placebo showed a reduction in diarrhoea, abdominal pain, bloating, stool frequency and urgency. More ENTEROSGEL® patients also showed improvement in their “quality of life” score and after the open label phase, 76% of patients reported adequate relief of their symptoms.

The trial also explored the microbiome of a small subset of patients to gain an understanding on the potential impact of ENTEROSGEL® on the gut. Although numbers were small, results suggest that ENTEROSGEL® may help reduce or eradicate some opportunistic bacteria, in particular Enterohemorrhagic E. coli (EHEC), Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium and Pseudomonas spp. The data also showed that H. pylori was less common in subjects following ENTEROSGEL® treatment than following placebo treatment.

In conclusion, ENTEROSGEL® is considered a safe and effective treatment of IBS-D and an important alternative to anti-diarrhoeal drugs such as loperamide.

How does ENTEROSGEL® Work in Acute Diarrhoea?

The basis for use in acute diarrhoea is that ENTEROSGEL® can adsorb (physically bind) bacterial toxins and viral particles associated with gastroenteritis. A recent lab study tested the adsorption of bacterial toxins released from Clostridioides difficile (C.Difficile), Shigella and E.coli, which can cause inflammation and damage to the mucosal cells lining the colon resulting in diarrhoea. The results showed that ENTEROSGEL® has substantial adsorption capacity for these bacterial toxins (2). This study supports previous investigations which have shown that ENTEROSGEL® can adsorb harmful substances and common viruses which can cause gastrointestinal disorders and acute diarrhoea.

A recent RCT investigating ENTEROSGEL® use in acute diarrhoea recruited 105 patients from ten GP surgeries across England (4). Patients were randomised to the treatment group, which received ENTEROSGEL® and oral rehydration solution for 8 days, or the control group, which received oral rehydration solution alone.

The study results showed that the duration of diarrhoea was significantly shorter in the ENTEROSGEL® group at 27 hours compared to 39 hours in the control group. ENTEROSGEL® was also shown to be well-tolerated and safe.

These findings support previous ENTEROSGEL® studies in children with acute diarrhoea (5-7) and show that ENTEROSGEL® is a safe and effective treatment for short-term diarrhoea and can reduce diarrhoea symptoms in all age groups.

We have recently completed and published a trial in The Gambia in children under 5 years of age with acute diarrhoea. This study generated pilot data which will help inform the design of a subsequent larger clinical trial in this demographic.

The study showed that the children taking ENTEROSGEL® in oral rehydration solution (ORS), had the duration of their diarrhoea reduced by nearly a day (~20 hours) compared to the control group.

How to Take Enterosgel?

  • Dosage. Acute diarrhoea.

    We recommend using the table in the Instruction For Use leaflet to work out the correct age related dose for your patient.

    ENTEROSGEL® is simple to take, it is a tasteless gel that you measure using a teaspoon or tablespoon and mix with room temperature water immediately before drinking. Most patients find the product tolerable, but juice, sparkling water or oral rehydration sachet can be added to the diluted  ENTEROSGEL® if required.

    To get the most benefit patients should start taking ENTEROSGEL® as soon after their diarrhoea symptoms begin. On day 1 they can take a double dose to start, then continue with a single dose after each loose stool (max 8 doses on first day). Then continue treatment with up to 3 doses per day until their stool returns to normal. ENTEROSGEL® can be taken alongside oral rehydration sachets to help prevent dehydration, especially in children. Most people find their diarrhoea stops within 36 hours of starting to take ENTEROSGEL®, but treatment can continue for 3-5 days if required.

    In line with the NHS website the precautions section states that if there is fever, blood in the stools, signs of dehydration, six or more episodes of diarrhoea in the last 24 hours, diarrhoea and vomiting at the same time, or severe continuous stomach-ache, that patient should seek immediate medical advice.

    For prescribing to children under 6 yrs: the 90g ENTEROSGEL® tube is the most cost-efficient variant.

    For prescribing to children over 6 yrs and adults: the 225g ENTEROSGEL® tube is the most cost-efficient variant.

  • Dosage. IBS-D

    Patients should be medically diagnosed with IBS-D before commencing treatment with ENTEROSGEL®. They can begin with 2-3 doses of ENTEROSGEL® per day for 2 weeks, if they see an immediate improvement in their symptoms they can remain on that dose for a further week and then start to tailor their dose to their daily symptoms.

    Some patients take a little longer to see an improvement and it may take 3-4 weeks before they see an improvement. They can either try to increase treatment to a double dose up to 3 times per day if their stool is loose or reduce to a single dose per day if their stool is normal (max 6 doses per day).

    Encourage patients that they are the best person to understand their body and their symptoms, so once they see an improvement, they can adjust their daily dose in response to their symptoms and lifestyle. If they are feeling stressed or may have eaten something that could trigger their symptoms, they can increase their dose. If their symptoms are under control, they can start to reduce their dose.

    Patients can take ENTEROSGEL® continuously for 30 days, then in line with medical device regulations for a short-term device, they should leave a break of at least 3 days before they begin another course. Many patients who have taken ENTEROSGEL® in the longer term (> 6 months) find they can reduce their dose to once a day or just when they have a flare in symptoms, and others can stop taking it as their IBS-D symptoms have improved.

    For prescribing in IBS-D the 225g ENTEROSGEL® tube is the most cost-efficient variant.

Current and Future Research

Enteromed Ltd and the manufacturer of ENTEROSGEL, Bioline Products s.r.o based in Czechia, are committed to continue further high-quality research for ENTEROSGEL use in other conditions. In countries outside of Europe, ENTEROSGEL is used for many indications relating to the gut, such as pelvic radiation disease, allergies, atopic dermatitis and even GI symptoms from COVID-19.

If you are interested in finding out more about ENTEROSGEL and our future research, please get in touch using our Contact us page.

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