The Functional Gut Clinic (FGC), the UK’s leading provider of specialist gastrointestinal (GI) diagnostics, has announced the launch of its dedicated GI Clinical Trials Division, establishing itself as the country’s first boutique, end-to-end clinical research provider focused exclusively on digestive health.
Gastrointestinal conditions affect millions across the UK, yet research in the field has often been fragmented, slow, or under-resourced.
FGC’s new division aims to change that, formalising and expanding the organisation’s long-standing research activity and positioning it as a premier partner for pharmaceutical, biotech, and microbiome companies developing next-generation therapies for conditions such as IBS, SIBO, reflux, motility disorders, and functional GI disease.
FGC enters the market with three major advantages over generalist clinical research organisations (CROs): First, the UK’s largest volunteer bank for digestive-health research, with 5,000 opted-in individuals living with digestive conditions.
Second, fast-track recruitment capability, with ethics approval to full enrolment achieved in under six months in recent studies. And third, unmatched diagnostic expertise, conducting over 12,000 GI physiology tests annually and operating the only independent UKAS-accredited GI physiology service in the country.
“Digestive health research has historically been slowed by two challenges: finding the right patients and understanding their physiology in enough depth,” said Professor Anthony Hobson, Founder of the Functional Gut Clinic.
“At the Functional Gut Clinic, we have built the UK’s largest bank of opted-in volunteers with digestive conditions, and we combine this with unparalleled diagnostic capability. Launching our Clinical Trials Division allows us to bring these strengths together to accelerate the development of new therapies and support companies working at the forefront of gut science.”
The division’s launch follows the recent success of a Phase 2a IBS study for EnteroBiotix, which enrolled 122 participants. FGC played a central role in recruitment, clinical assessment, and ongoing care, enabling the study to move from ethics approval to full enrolment in under six months.
“The Functional Gut Clinic played a pivotal role in enabling the successful delivery of our Phase 2a trial,” said Dr James McIlroy, Founder & CEO of EnteroBiotix. “Their ability to deliver a compliant study within agreed timelines, assess patients with precision and provide high-quality clinical oversight made a meaningful difference to the study.