![]() It also means zero hospital visits which makes participation safer and easier for all. “Virtual trial capability empowers patients it allows any patient anywhere in the country to access the trial. ![]() 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. None of this was possible before the trial.” UK’s first virtual trial for IBS patientsĬhief 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. 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. Within a week I was down to just a few trips to the bathroom per day, which was an 85% reduction in 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. I had tried so many different medicines and herbal remedies and nothing had given me any respite from my symptoms. Life-changingĪnthony, 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. 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.Ī 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. Enterosgel ® participants also saw a marked improvement in other IBS symptoms such as bloating, stool frequency and urgency. The trial results showed that significantly more people who received Enterosgel ® experienced less abdominal pain and diarrhoea compared to participants who received the placebo. This new approach resulted in 67% faster recruitment to the trial compared to traditional on-site visits. 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.ĭuring 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. A virtual trial led by Newcastle researchers has found a new treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D). ![]()
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