The Functional Gut Clinic (FGC), a provider of specialist gastrointestinal (GI) diagnostics, has announced the launch of its dedicated GI Clinical Trials establishing the organisation as the country’s first boutique, end‑to‑end clinical research provider focused exclusively on digestive health.
Gastrointestinal conditions affect millions of people in the UK, yet clinical research in this area has often been fragmented, slow or under‑resourced. FGC’s new Clinical Trials Division aims to change this. The new division formalises and expands FGC’s long‑standing research activity, positioning the organisation as a uniquely capable partner for pharmaceutical, biotech and microbiome companies developing next‑generation therapies for conditions such as IBS, SIBO, reflux, motility disorders and functional gastrointestinal (GI) disease.
FGC enters the market with three major advantages that set it apart from generalist CROs:
- The UK’s largest volunteer bank for digestive‑health research, with 5,000 opted‑in individuals living with digestive health conditions
- Fast‑track recruitment capability, demonstrated by completing ethics approval to full enrolment in under six months in recent studies
- Extensive diagnostic expertise, delivering over 12,000 GI physiology tests each year and operating the only independent UKAS‑accredited GI physiology service in the country. This means participants can be screened rapidly and with a level of clinical precision that significantly streamlines study start‑up
Together, these capabilities allow FGC to recruit rapidly, screen accurately, and deliver high‑quality digestive‑health trials across multiple UK sites. Professor Anthony Hobson, Founder of the Functional Gut Clinic comments: “Digestive health research has historically been slowed by two challenges: finding the right patients and understanding their physiology in enough depth.”
“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.”
Landmark trial success demonstrates capability
The launch follows the recent success of a Phase 2a IBS study for EnteroBiotix, which enrolled 122 participants. FGC played a central role in the trial, supporting participant recruitment, clinical assessment and ongoing care. Recruitment was enabled using FGC’s research volunteer database, allowing the study to progress 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,” explains Dr James McIlroy, Founder & CEO, 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. Professor Hobson’s presentation of the data at Digestive Disease Week 2025 as a late breaking oral presentation reflects the strength of our collaboration, and we look forward to expanding our work together as we progress into the next phase of development.”
A specialist partner for GI‑focused clinical development
FGC has already delivered research programmes for leading global companies including ADM Protexin (Bio‑Kult), Reckitt Benckiser (Gaviscon), Medtronic and EnteroBiotix, supporting studies across probiotics, OTC medicines, medical devices and microbiome therapeutics. Unlike large generalist CROs, FGC offers a boutique, specialist model tailored to the complexities of digestive‑health research.
Playing a pivotal role in the delivery of the new Clinical Trials division is Sam Treadway, Chief Scientific Officer at the Functional Gut Clinic. He adds: “By integrating our diagnostic expertise with our research infrastructure and a large, engaged volunteer community, we can deliver trials that move quickly without compromising scientific rigour. We provide sponsors with a specialist partner who understands the nuances of GI disease far better than a general research organisation.”
The launch of the Clinical Trials Division follows a £5.75 million investment from Foresight Group, announced in 2025. The investment is supporting expansion of FGC’s national footprint, growth of its clinical research team and strengthening of its trial‑delivery infrastructure. FGC operates three permanent clinics in Manchester, Cambridge and London, alongside several collaborative clinics across the UK.
Companies interested in conducting digestive‑health research can learn more at: https://thefunctionalgutclinic.com/gi-clinical-trials.
