Virtual trial discovers all-in-one treatment for IBS with diarrhoea
A virtual study led by researchers in Newcastle upon Tyne has found a new treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D).
The results of the RELIEVE IBS-D trial have been published in the leading international journal “GUT” and show that the intestinal adsorbent Enterosgel® is a safe and effective treatment for the main symptoms of IBS-D, a condition that affects many people in the UK and can have a major impact on quality of life.
During the COVID-19 pandemic, study sponsor Enteromed worked closely with researchers at the National Institute for Health and Care Research (NIHR) Patient Recruitment Centre: Newcastle to transform the RELIEVE IBS-D study into one of the first fully virtual UK clinical trials. This allowed people from across the country to take part in the study without having to travel. This new approach resulted in 67% faster recruitment to the trial compared to traditional on-site visits.
The trial results showed that significantly more people who received Enterosgel® experienced less abdominal pain and diarrhoea compared to participants who received the placebo. Enterosgel® participants also saw a marked improvement in other IBS symptoms such as bloating, stool frequency and urgency.
Overall, the results show that Enterosgel® is an effective treatment and can improve quality of life for IBS-D patients, many of whom experience incapacitating symptoms.
A total of 440 patients with IBS-D participated in the study at 28 sites in England, including GPs, hospitals and a private clinic, before switching to a “virtual” trial during the pandemic.
Anthony, a participant from Newcastle who took part in the open-label phase of the study (during which participants know which treatment they are getting), said: “I have had IBS for the majority of my life and have spent much of that time visiting doctors and having tests. I had tried so many different medicines and herbal remedies and nothing had given me any respite from my symptoms. As I got older, my symptoms got progressively worse until I was going to the bathroom 20 times per day and was in constant pain. It had completely affected my life.
“Enterosgel® was a game changer for me. Within a week I was down to just a few trips to the bathroom per day, which was an 85% reduction in my symptoms. There has been a complete reversal in my professional life and I have begun having a social life and have been able to go on holiday. None of this was possible before the trial.”
Chief Investigator Professor Yan Yiannakou, Clinical Director of the NIHR Patient Recruitment Centre: Newcastle, said: “This study is certainly the UK’s first virtual trial for IBS patients, and one of the UK’s first virtual trials of an interventional therapy. It is a pathfinder for delivery of clinical trials and may help start a revolution in the way we run clinical trials post COVID-19.
“Virtual trial capability empowers patients; it allows any patient anywhere in the country to access the trial. It also means zero hospital visits which makes participation safer and easier for all.
“Only the quick roll-out of the virtual approach enabled us to successfully complete this trial and show how effective Enterosgel® is as a treatment for the main symptoms of patients with IBS-D. Current therapies are limited and being able to offer another option will be a lifeline to some patients.”
Dr Carol Howell, Research Director of Enteromed Ltd, the life science company conducting the trial, said: “The RELIEVE IBS-D trial team went to great efforts to keep IBS research going throughout the pandemic. We were proud to work closely with the team at the Patient Recruitment Centre: Newcastle and all our other 28 sites to make the trial such a success. Being able to offer an effective treatment to IBS-D patients and help improve their quality of life is a real achievement."
For more information or to request an interview, please contact Lisa Howarth on 07342058139, or email firstname.lastname@example.org.
Professor Yan Yiannakou, Chief Investigator of the RELIEVE IBS-D trial and Clinical Director of the NIHR Patient Recruitment Centre: Newcastle, is available to be interviewed in person on Wednesday 29 June, 4pm-5pm. Further telephone interviews may also be arranged on Thursday 30 June.
Anthony, a RELIEVE IBS-D trial participant, is available to interview 12pm-4pm on Wednesday 29 June or Thursday 30 June.
According to the latest ROME IV diagnostic criteria, IBS affects 4% of the UK population; however, previous criteria and surveys of the general public, many of whom do not seek medical advice for the disorder, suggest levels are much higher at 10-20%. Prevalence is higher in women than in men, with one third of people experiencing the diarrhoea-type IBS (IBS-D), with symptoms having a huge impact on their quality of life. Patients with IBS-D suffer debilitating and often embarrassing symptoms of diarrhoea, abdominal pain, bloating and urgency in needing to go to the toilet. Many organise daily activities around their condition, refusing social occasions and amending plans to be near public toilets. Studies also show their work, life and intimate relationships are severely affected by IBS symptoms. Fewer than one-third of people with IBS are satisfied with their current therapies used to treat their IBS symptoms, so there is a real need to find new approaches and treatments to help these people.
About the RELIEVE IBS-D trial
The RELIEVE IBS-D trial tested the efficacy, tolerability and safety of the intestinal adsorbent Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D). Participants aged 16-75 years with IBS-D symptoms reported during a 2-week screening phase, were recruited. The trial had an 8-week double-blind phase when participants either received Enterosgel or placebo, followed by an 8-week open label phase when all participants took Enterosgel. Participants who experienced adequate relief of their symptoms were followed up at a further 8 weeks. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The virtual version of the trial involved an online pre-screening questionnaire, consultations by video or phone, and participants completing an electronic consent form. In an unusual step, after the trial completed the participants were the first to discover the trial results through an interactive participant webinar.
Enterosgel® is a drug-free treatment. It is a class IIa medical device, currently used as a treatment for acute diarrhoea and chronic diarrhoea associated with IBS. It is an intestinal adsorbent composed of an organic mineral, in the form of a tasteless gel that is mixed with water to be taken orally. Enterosgel® works by physically binding to harmful substances in the gut such as bacterial toxins, viruses and other molecules that can cause diarrhoea and other gastrointestinal symptoms and removes them naturally from the gut. A recent UK study showed that it significantly reduces the duration of acute diarrhoea, and the current RELIEVE IBS-D study shows that it is effective in treating the main symptoms of IBS-D.