NOW RECRUITING ACROSS THE UK
Have you got IBS & Constipation?
We are looking for people who have been living with Irritable Bowel Syndrome (IBS) and constipation for at least 6 months to take part in a research study.
We are looking at how medication that changes the microorganisms in the gut can impact IBS.
The study is running in: Bristol, Cambridge, Durham, Glasgow, High Wycombe, Leicester, London, North London, Manchester, Newcastle and Romford.
What is the study?
The aim of the study is to assess whether the study drug, EBX-102-02, is safe and effective in people with Irritable Bowel Syndrome with constipation as the main symptom (IBS-C).
EBX-102-02 (the study drug) contains dried, live, micro-organisms which have been safely prepared from extensively tested human stool (poo). This type of treatment is often called ‘Intestinal Microbiota Transfer’ (IMT).
We’re shaping the future of IBS treatment.
Who can take part?
We’re looking for individuals who:
Are male or non-pregnant female, aged 18–70
Have been living with IBS and constipation for at least 6 months
Live in the UK and are able to come to one of the study sites in person
Are happy to take tests in the clinic and give samples as explained by the study team
Constipation needs to be the main symptom of your IBS.
If you suffer mainly from diarrhoea, this study is not right for you.
Aside from meeting the criteria for IBS-C, you’ll also need to meet the remaining inclusion and exclusion criteria to take part. This will be assessed by a member of the study team.
Where can I take part?
The study is running at sites across the UK. Choose whichever is easiest for you to reach.
Bristol
Cambridge
Durham
Glasgow – Glasgow Royal Infirmary
High Wycombe
Leicester
London
North London
Manchester
Newcastle
Romford
What does the study involve?
You would receive the study treatment in the form of eight capsules taken at each time point. This will happen on four of the visits. There is a 2 in 3 chance that the capsules will contain active treatment and a 1 in 3 chance that it will be a placebo (dummy tablets).
You’ll be asked to come to the clinic in person for study appointments, take part in investigations, complete questionnaires and keep a bowel diary.
Tests will include:
stool samples
urine samples
blood samples
methane breath test
questionnaires about your symptoms and wellbeing
daily bowel habit diary
If any of the tests taken as part of the study identify information that might be of relevance to your health and wellbeing, we will let you and your GP know.
Expenses and compensation
You will be reimbursed for reasonable costs related to study activities, such as travel, parking or light refreshments on study visit days. To get these expenses reimbursed you may be asked to provide a receipt showing your expenses.
In addition, you will receive a stipend of up to £500 at the end of the study to recognise the time, effort, and inconvenience involved in taking part.
You will not share in any profits as a result of this research carried out on your health information and samples collected.
How taking part works
Answer the prescreening questions
You’ll be asked some questions about your IBS. These include 3 consent questions, 19 medical questions and 6 contact details (only collected if considered eligible). Your answers are used to work out whether you are potentially eligible.
You see the result straight away
We expect that about half of the people we invite will not be eligible for this study, so this step means you are only referred to a study site if you are potentially eligible.
The study team gets in touch
If you are potentially eligible, the team at your nearest site will contact you to talk through the study and your eligibility, including your symptoms, any current medication, and relevant medical history.
You decide
You’ll be sent a full Patient Information Sheet. Taking part is entirely your choice, and you can change your mind at any time.
RISE IBS-C Prescreening Questionnaire
Thank you for your interest in the RISE IBS-C clinical trial. This short questionnaire will help us understand whether you may be suitable to take part. If you appear to be eligible, a member of the study team will contact you to discuss the next steps. You do not need to have a formal diagnosis of IBS to complete this form.
There are 19 medical questions. You do not need to give any personal details unless the study looks like a possible fit.
RISE IBS-C
Restoring intestinal symbiosis for efficacy in IBS-C
Questions about the study? Contact the study team:
Shinofa Rizan
RISE.Recruitment@enterobiotix.com
IRAS ID: 1012072
This study is being run with the support of the NHS and the National Institute for Health and Care Research, working in partnership with EnteroBiotix.
Find out more about the study on ISRCTN - ISRCTN15681288: Restoring intestinal symbiosis for efficacy in IBS