EGIS TRIAL

Investigating the Effect of Prebiotic Galacto-oligosaccharides (GOS) on Gastrointestinal Symptom Severity in Patients with Irritable Bowel Syndrome (IBS)

• Actively recruiting patients diagnosed with IBS
• Involves daily consumption of a food supplement or placebo, 3 hospital study visits and 3 phone calls during an 8 week intervention period
• Study is enrolling patients until 31st December 2023

Purpose of the clinical study:

To assess whether daily consumption of a food supplement containing GOS for 8 weeks can reduce IBS symptom severity

Who may participate?

• Patients aged 18-64 years with an IBS diagnosis
• Must be currently maintaining a normal, stable dietary pattern, and therefore not following a special diet (e.g. low FODMAP, gluten free, low carb or sugar-free, or energy restricted diet)
• Patients may not participate if they have had surgery to the mouth, throat, stomach, or gut within the 4 weeks prior to participation (or planned during the study), or if patients suffer from other severe illness(es) or medical condition(s)
• Must be willing to temporarily stop taking certain alternative therapies used to manage IBS symptoms (subject to review at the recruitment phase)

What happens if you decide to participate?

Participation is entirely voluntary, and you may withdraw at any time. You will receive compensation for travel and parking expenses incurred to attend the 3 study visits at the hospital.

What to do if you are interested in participating?

The study is conducted at the following sites in the UK:

GB-01 Wingate Clinical Trials Facility, Bart’s & The London School of Medicine and Dentistry, Queen Mary University, 26 Ashfield Street, London E1 2AJ;

Email: wingatectf@qmul.ac.uk; Phone: 0207 882 8960

GB-02 Neurogastroenterology Unit, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT;

Email: mft.neurogastro@nhs.net; Phone: 0161 291 4189

GB-03 Leeds Teaching Hospitals, St James’s University Hospital, Beckett Street, Leeds, LS9 7TF;

Email: jaqueline.brett@nhs.net; Phone: 0113 206 8439 / 68753

GB-04 NIHR Patient Recruitment Centre, Newcastle Campus for Ageing and Vitality, Westgate Road, Newcastle upon Tyne, NE4 6BE;

Email nuth.prcnewcastle@nhs.net; Phone: 0191 282 3172

GB-05- County Durham & Darlington NHS Foundation trust, University Hospital of North Durham, North Road, Durham, DH1 5TW

Email cddft.egis@nhs.net; Phone: 0191 333 2521

Text Reference Number	EGIS-01
Version Number	V 2.1
Date	16May2023

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