The ATLANTIS study v1.0
Research type
Research Study
Full title
Amitriptyline at Low-dose and Titrated for Irritable Bowel Syndrome as Second-line Treatment (The ATLANTIS study): A Double-blind Placebo-controlled Trial
IRAS ID
252282
Contact name
Alexander Ford
Contact email
Sponsor organisation
University of Leeds
Eudract number
2019-000324-17
Duration of Study in the UK
3 years, 1 months, 31 days
Research summary
Irritable bowel syndrome (IBS) is a common, chronic, functional gastrointestinal (GI) disorder, and represents a significant financial burden to the health service. Current first-line treatment of IBS in primary care includes dietary and lifestyle advice, soluble fibre, and antispasmodic drugs. However, if these treatments are ineffective, GPs are often left with few treatment options, meaning people are frequently referred to see a specialist in secondary care, where they may be prescribed tricyclic antidepresents (TCAs) such as amitriptyline. NICE guidelines state that GPs should consider TCAs as second-line treatment for IBS if laxatives, loperamide, or antispasmodics have not helped. However, there is limited evidence to support this statement and as result there is uncertainty as to whether TCAs are effective for the treatment of IBS in primary care. The overall aim of this study is to determine the clinical and cost-effectiveness of low-dose amitriptyline as a second-line treatment for IBS in primary care.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0150
Date of REC Opinion
2 Aug 2019
REC opinion
Further Information Favourable Opinion