A large clinical trial “RELIEVE-IBS-D” for patients with diarrhea predominant IBS (IBS-D) included in the National Institute for Health Research portfolio has started recruitment in England. The trial is using some of the latest research technologies to collect data and new information about IBS-D.
This trial, which has been developed with patients in mind, is currently recruiting over 400 patients aged 18-75 years old in 27 NHS GP and hospital sites across the country, with the primary objective to show the effectiveness of an oral intestinal adsorbent, Enterosgel in the treatment of IBS-D.
The trials design has been developed according to the guidelines of EU and US regulatory authorities, while ensuring patient friendliness. The study treatment is delivered directly to the patient’s home, and the simple electronic diaries take only a couple of minutes each day to complete on a mobile phone.
The Chief Investigator, Prof Yan Yiannakou, from Durham and Newcastle, helped design the trial, together with a panel of other NHS experts that includes key opinion leaders in the gastroenterology field, Professor Charles Knowles, Professor Peter Whorwell and Professor John Mclaughlin, as well as research general practitioner Dr Preeti Pandya.
The Chief Investigator, Prof Yan Yiannakou, from Durham and Newcastle comments:
We asked our patients what they wanted from a study and have used their feedback to make the study ‘patient-friendly’. So, the diaries and questionnaires are kept to a minimum and every patient gets to try the treatment in what we call an ‘open label phase’. But the study is also scientifically very robust and should show exactly how effective this treatment is. Patient recruitment to the study is going really well, leveraging many new techniques and organizations to maximize recruitment and the study is on track to complete recruitment by the end of 2019.”
Some patients in the study will also have the opportunity to volunteer for more advanced tests, looking at the bacterial populations and chemicals in their stool with the help of the innovative technology GI-MAPTM, or undertaking the latest gut motility assessments using the new functional MRI scanning and GIQuant image processing software (Motilent Ltd, UK).
Irritable bowel syndrome (IBS) is a common condition, affecting around 1 in 10 of the adult population. It can cause unpleasant symptoms, including abdominal pain, bloating and bowel symptoms. Patients can be constipated (IBS-C), or suffer diarrhea (IBS-D), or a mix of both. It is estimated that approximately a third of patients with IBS experience diarrhea as their predominant bowel habit, causing a wide range of unpleasant symptoms, including abdominal pain and bloating, severely impacting their professional and personal lives.
Dr Preeti Pandya from The Village Practice, Thornton-Cleveleys says:
IBS is not a dangerous medical condition, but it has significant impact on patients’ lives and on the NHS. It is an illness that can produce devastating/disruptive symptoms in the day to day life. Despite following the NICE guidelines, IBS is very difficult to treat with only partial success of current treatments.”
The causes of IBS are complex and not fully understood, but it is accepted that many patients develop the condition after an infection. Part of the problem might be a persistently activated gut immune system following such an infection; and this could lead to release of immune chemicals and influence changes in the bacterial population of the gut (the microbiome), so changing the consistency of the bowel motion. Many other factors may also play a part in the production of symptoms.
Worldwide, oral intestinal adsorbents, such as Enterosgel® are widely used to treat diarrhea in children and adults. However, in the UK this method of treatment is uncommon. This study promises to become a breakthrough for more widespread use of intestinal adsorbents in treatment of diarrhea and will open the door for new research opportunities, especially benefiting vulnerable groups of the population.
Some patients have already completed the study, one patient outlined their experience of the study:
I was contacted by letter about being part of research into IBS-D. Having nothing to lose, having tried everything else, I decided to give it a go. I had no expectations, just thought it was worth a try. Well, all I can say is the difference it has made to my life. I feel cured of a condition I have had for years. And I am so grateful for the lovely research nurse and the doctor I saw. I gather I cannot give their names on the review. But thank you! I know lots of people just feel they are stuck with IBS symptoms, but I have found a treatment that works for me and thought others would find it useful. I believe the surgery is happy to let others try it, too. Having never been part of the research before I wasn’t sure what to expect. But apart from a few phone calls and few surgery visits all I had to do was take the treatment and fill a simple diary. I have confidence to go out and enjoy life and I am so grateful.”