Clinical Trial in Patients With IBS Diarrhoea

RELIEVE IBS-D study 2021 “Enterosgel in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults”.

In our large UK clinical study, 440 patients diagnosed with IBS-D and living with frequent diarrhoea and abdominal pain were given Enterosgel for the first time.

Our aim was to show that Enterosgel could relieve patient’s IBS-D symptoms and help them get out and about again without worrying about the nearest toilet and enjoying an improved quality of life. 

On average twice a day for 8 weeks participants from 28 different GP surgeries, hospitals and a virtual site, took drug-free Enterosgel or placebo, then using an online diary recorded their daily symptoms. Everyone got a chance to try Enterosgel for a further 8 weeks in the open label phase, followed by another 8 week follow up phase when patients could choose whether to take it.

People were divided into 2 groups by chance (called randomisation) each group were given either Enterosgel or the placebo.  This study was also “double-blinded”, so that both the participants and doctors did not know if the treatment or the placebo was given. 

Read the study article published in the leading international gastroenterology journal GUT

Improved Abdominal Pain and Diarrhoea

The Enterosgel group had a higher percentage of patients with both a decrease in their abdominal pain and a reduction in days with a loose stool, compared to the placebo.

The results showed a significant reduction in:

  • Abdominal pain
  • Diarrhoea
  • Bloating
  • Urgency

76% reported adequate relief of symptoms

At the end of the open-label phase when all participants were taking Enterosgel, 76% reported adequate relief of their IBS symptoms.

74% increased or maintained treatment benefit

At the end of the 8 week follow up phase, 74% said they had an increased or maintained treatment benefit from taking Enterosgel.

Improvement in Quality of life

Participants reported an improvement in their quality of life score after taking Enterosgel.

Reduced loperamide use

Participants reported a 38% reduction in use of loperamide after taking drug-free Enterosgel.

What were the results of the study?

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 adequate relief of their symptoms.

What Doctors Say?

”This study showed how Enterosgel® is an effective IBS-D treatment. Being able to offer another option will be a lifeline to some patients. This study showed that 76% of patients that took Enterosgel® reported adequate relief of their IBS symptoms.”

Dr Yan Photo_2
Prof. Yan Yiannakou
Chief Investigator of IBS-D study, Consultant Neurogastroenterologist, University Hospital of North Durham

What Side Effects Did the Participants Have?

Less side effects reported. Slightly more participants in the placebo group (9%) reported related side effects than in the Enterosgel group (7%). The type of side effects reported were similar in both groups, with nausea being the most common, in just 4% of participants in both groups.

What Participants Said?

I have had IBS most of my life, I have tried so many different medicines and herbal remedies and nothing gave me any respite. Enterosgel was a game changer for me, within a week I was down to just a few trips to the bathroom per day. I have begun having a social life and gone on holiday, none of this was possible before.”

Watch video review >>>

Anthony Anderson

“I have IBS and used to go to the toilet 3-4 times a day and have a constant bloated stomach. After taking Enterosgel for a few weeks it reduced my toilet visits to once a day and hardly any bloated stomach or discomfort. As my symptoms have vastly improved, I am not taking it at the moment, but I would definitely recommend Enterosgel to anyone thinking of trying it.”

Watch video review>>>

Eric Davidson
Eric Davidson
Tyne and Wear

“ I suffer with IBS-D and prior to taking Enterosgel I often visited my GP and was struggling to find something to help relieve my symptoms, nothing worked. Enterosgel has been the answer to my prayers, my quality of life has improved significantly, I feel normal when taking it, which is a lovely feeling.”

Watch video review >>>

Jo Wilson
Jo Wilson

“In 2020 I started having severe diarrhoea in the mornings needing me to dash to the toilet and this continued during the day up to 6-8 times. I also had weight loss and severe stomach pains, after tests my GP diagnosed IBS diarrhoea, but I wasn’t prescribed anything and left to get on with my life. After joining an IBS trial, I was introduced to Enterosgel, immediately it helped my symptoms so much and made me feel so much better. I have been taking Enterosgel now for 2 years and I couldn’t live my life without it”

Watch video review >>>

Alison Hollard
Alison Hollard

Clinical Trial in Patients With Acute Diarrhoea

A 2019 randomised controlled clinical study investigated Enterosgel use in acute diarrhoea.

This UK study recruited 105 patients with acute (short-term) diarrhoea including gastroenteritis (stomach bugs) and diarrhoea from other causes, who were given Enterosgel for the first time.

Our aim was to show that Enterosgel could reduce patient’s diarrhoea symptoms faster than standard care with oral rehydration solution. Without the need to take any drugs. 

Patients were randomised to the treatment group which received drug-free Enterosgel 3 times per day and oral rehydration solution for 8 days, or the control group which received oral rehydration solution alone. They recorded their symptoms in a daily diary and their stool was tested for pathogens.

Reduced Duration of Diarrhoea

The duration of diarrhoea was significantly shorter in the Enterosgel group at 27 hours compared to 39 hours in the control group.

72% diarrhoea resolved within 36 hours

72% of patient’s diarrhoea was resolved after 36 hours of taking Enterosgel.

More side effects in control group

The total number of side effects reported was higher in the control group than in the Enterosgel group.

20% of patients had a stool pathogen

Enterosgel has been shown in lab-based studies [1] to adsorb toxins from pathogenic bacteria such as E.coli, C.difficile and Shigella and viral particles such as rotavirus, these can cause gastroenteritis and diarrhoea symptoms.

What Doctors Say?

I recommend Enterosgel to my patients, as this study showed that Enterosgel can reduce the duration of acute diarrhoea and relieve associated symptoms, and is one of the few safe treatment options currently available for children

Preeti-Photo 100
Dr Preeti Pandya
Chief Investigator of study, Practicing GP

What Were the Results of the Study?

The study results showed that Enterosgel treatment led to a significant reduction in the duration of diarrhoea in adults with acute diarrhoea, compared with standard care alone.

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