Clinical Trials for Medicines & Medical Devices
From protocol design and clinical trial conduct to data analysis and regulatory-standard clinical trial reports, the Functional Gut Clinic delivers end-to-end clinical trials tailored to your medicines and medical devices
.
Our team brings considerable scientific expertise in designing efficient, cost-effective studies with focused, robust endpoints—ensuring your research meets the highest standards.
Speak to our clinical team within 2 business days
We offer
Functional Gut Clinic
GI-specialist study design
Existing partnerships with other key opinion leaders
End-to-end trial management
Fast recruitment and high retention rate
Gold-standard GI testing and clinical assessments
Access to advanced biomarkers
Expert interpretation and analysis of data
Publication support
Other CROs
Generic study templates
Limited GI expertise
No biomarker integration
No claims guidance
Slower recruitment
No HCP interpretation
What is a clinical trial for a medicine or medical device?
A clinical trial for a medicine or medical device is a structured study that evaluates safety, efficacy, and performance in real patients under controlled conditions. For gastrointestinal-focused medicines and devices, this means measuring outcomes such as symptom reduction, bowel regularity, microbiome modulation, gut barrier integrity, and quality of life.
Why you should consider a clinical trial?
Credibility sells: Clinicians, payers, and patients demand proof.
Regulatory alignment: Studies designed to meet MHRA and EU standards, ensuring robust data for health claims and global submissions.
Marketing advantage: Evidence-based positioning accelerates adoption by healthcare professionals and payers. Published data strengthens your product’s value proposition in competitive markets.
Long-term return of investment: Published data strengthens brand authority, supports reimbursement, and can be leveraged for global submissions.
Why choose the Functional Gut Clinic for your clinical trial
From concept through to publication
We can take your product through the entire research cycle, from protocol design and clinical trial conduct to data analysis and regulatory-standard clinical trial reports. We deliver end-to-end clinical trials tailored to you.
Cutting-edge study endpoints
We offer a wide range of investigations and assessments, novel technologies, advanced biomarkers and validated questionnaires to demonstrate the safety and efficacy of your product.
Fast recruitment and high retention
Our extensive participant databases and advanced recruitment strategies enable us to identify and enrol eligible candidates faster than traditional methods. This streamlined approach not only accelerates study timelines but also ensures targeted participant selection. As a result, we consistently achieve above-average retention rates and deliver reliable, compliant data.
Our expert team
Our specialists ensure trials deliver high-quality, clinically relevant outcomes that make for highly publishable research.
Our research capabilities
Gastrointestinal assessments
Stool microbiome assessments
Gut permeability testing
Small intestinal bacterial overgrowth tests
Intestinal transit studies
Hydrogen sulphide assessment
Intestinal methanogenic overgrowth assessment
Carbohydrate malabsorption testing
Oesophageal manometry
24-hour reflux test
Gastric emptying test
Other
assessments
Validated clinical outcome assessments
Patient-reported outcome assessments (ePRO, eCoA)
Quality of life assessments
Safety assessments
Biochemistry and haematology
Digital biomarkers
Nutritional biomarkers
Lifestyle questionnaires
Patient satisfaction
Anthropometrics
Trusted by leading brands
What our partners say
"Working with the Functional Gut Clinic on our clinical study was a great experience. The team is highly professional, with great attention to detail and an in-depth expertise in the area of gut health. The study was conducted in the most robust way possible, with timely sample and data analysis. The study report was thorough and was provided in a readily usable format. The team did a wonderful job of keeping us appraised of any challenges or delays to any part of the study. Overall, it was a very positive experience and one that Brightseed would be happy to repeat when another opportunity arises."
"Our collaboration with the Functional Gut Clinic has been very exciting and productive. Together, we are working to identify novel molecular biomarkers for gut health, with the shared goal of enabling earlier diagnosis and better preventive management. In our current project, we are exploring urinary microRNA as potential biomarkers for Irritable Bowel Syndrome — an area with significant unmet clinical need. With several exciting genomics-driven biomarker discovery projects already in the pipeline, I look forward to strengthening this partnership and advancing impactful research together.”* – Prof. Arijit Mukhopadhyay"
"It was a pleasure to work with the Functional Gut Clinic who conducted a pilot study of our product in participants with constipation. They provided a hassle-free experience in conducting a clinical trial, with the results written up and presented by the FGC team at a national conference."
FAQ
How long does it take to start a study?
From study design to patient recruitment can take less than 3 months, depending on the complexity of the study and whether regulatory agency approval is required.
How much does a study cost?
The size, duration and complexity of a study will determine its cost. The FGC offers industry-competitive costs with streamlined, efficient clinical operations.
What clinical operations services does the FGC offer?
FGC offers end-to-end clinical trial services, including study design and protocol authoring, site setup and recruitment, data management and analysis, study report and publication authoring.
How many clinical sites does the FGC have?
FGC has three fully operational clinical sites located in London, Cambridge and Manchester, with the facility to work with other satellite and NHS sites as required.
Can you advise on the best way to conduct a piece of research to demonstrate how our product works?
That’s what we’re best at. Our team has experience in different trial designs and outcome measures to showcase your product.
Who will be able to see the results of a trial conducted by the FGC?
It’s good practice to publish results of findings in peer reviewed journals, conference abstracts or on a clinical trials database. However, your results belong to your company, we can advise on how best to publicise them and take you through the whole process.
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