Patients in GP surgeries across West Yorkshire are being invited to take part in a large trial of low-dose amitriptyline for irritable bowel syndrome (IBS).
Researchers from the Universities of Leeds, Southampton and Bristol are coordinating the trial, which is now open for recruitment.
Irritable bowel syndrome is a common gut disorder affecting one in ten people. Abdominal pain, bloating, and altered bowel habit affect patients’ quality of life substantially, and can force them to take days off work.
Low-dose amitriptyline is recommended as a treatment option for people who have persistent, troublesome IBS symptoms. It is thought to work at low doses in IBS because it has pain-relieving properties and changes bowel activity. However, there have been no large studies done in primary care to test whether or not it works.
This study, known as ATLANTIS (Amitriptyline at low-dose and titrated for IBS as second-line treatment) is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme, and will recruit over 500 people with IBS, who will receive either amitriptyline or a placebo tablet for at least six months.
Participants will be recruited from general practices across three hubs within Yorkshire, the South, and South West of England.
Potential patient benefits
Co-Chief Investigator Alexander Ford, Professor of Gastroenterology at the University of Leeds and Honorary Consultant Gastroenterologist at Leeds Teaching Hospitals NHS Trust, said: “This is an incredibly exciting study.
“Tricyclic antidepressants have been used, at low dose, for the treatment of IBS in hospitals for many years, but their effectiveness in primary care is unknown. Ours will be the first large study to test whether they work in this setting. The work is therefore of considerable importance for people living with IBS, their families, the NHS, and society as a whole.”
Professor Amanda Farrin, from the Clinical Trials Research Unit at the University of Leeds, said: “We are delighted to be collaborating in this important study investigating the effects of low-dose amitriptyline for people with IBS, which has the potential to provide significant patient benefit.
“The Trials Unit will implement and oversee the study, providing design, trial management and analysis expertise.”
Dr Sarah Alderson, a general practitioner and lecturer at the University of Leeds, added: “Irritable bowel syndrome is common and we often see people in our surgeries whose lives are badly affected by it.
“We are really pleased to be able to offer our patients the opportunity to take part in this important clinical study.”
The research is due to complete in June 2022.