A virtual trial led by Newcastle researchers 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 NIHR Patient Recruitment Centre: Newcastle to transform the RELIEVE IBS-D trial into one of the first fully virtual UK clinical trials, allowing 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 trial 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.”
UK’s first virtual trial for IBS patients
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.”
Elena Markaryan, CEO of Enteromed Ltd, the life science company conducting the trial: “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 NHS 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.”