As a spin out of the APC Microbiome Ireland, the world-leading microbiome research centre, Atlantia Clinical Trials has extensive experience in conducting human clinical trials in multiple health. Atlantia provides its clients with state-of-the-art microbiome research through all stages of the clinical trial process from the design and conduct of the study right through to the final report.
Consumers are increasingly focused on health and nutrition in their decision-making. Alongside this, interest and understanding of the importance of the gut microbiota in health and disease continues to grow. The global market for functional foods and beverages is worth $216.4 billion today and is expected to grow to $324.4 billion by 20271. The biotics industry provides an expansive pool of new product opportunities. For biotic products to be fully developed and successfully marketed, their safety, identity, purity, and potency need to be clearly defined. Alongside this, quality pre-clinical and clinical studies are required for proof of benefits.
The Atlantia team will be present at CPHI 2022 on stand 110G70. Make sure to book your meeting with them!
To maximise chances of success when conducting such studies, there are several elements of the study design that need careful consideration. Firstly, one should consider the expected level of non-responders within the target population and integrate this into the power calculations. Inclusion and exclusion criteria should be defined to capture the specific population of interest and eliminate any confounding factors, while remaining true to reality. Biological sample collection methodology and analysis that allow appropriate microbial profiling of the study population should also be carefully planned and may include multiple sample times. Furthermore, study product should be administered at a quantity that is robust enough to cut through the established challenges of diet adherence and reporting while meeting market objectives, e.g. commercially available doses. For synbiotics, a health outcome and a microbiota outcome must be achieved in the same study. There should be one primary endpoint and, if this is to meet EFSA requirements, it must be a beneficial physiological effect. Including specific biomarker, endpoints will also help in pertaining mechanisms. Finally, closely following ICH-GCP and EQUATOR guidelines (in particular CONSORT 2010 and SPIRIT 2013) provide the best opportunity for conducting a high-quality clinical study.
In summary, the field of biotics is vast and continues to grow. It is comprehensible that there is confusion among clinicians and consumers in understanding and differentiating the diverse products on the market. Unambiguous approved health claims will be a key aid in reducing this confusion. EFSA has improved guidance for the industry regarding the requirements for successful claims7 and continues to work with stakeholders to further develop these4. Within the current limitations, postbiotics, especially non-viable microbial products, have several advantages including known molecular structure, use in purified forms, increased stability, and often known specific mechanisms of action. These diverse products pertain to an array of highly desired beneficial properties. To realize their potential there is a significant need for definition consensus and the delivery of high-quality clinical trials to validate health claims.
Book your meeting with the Atlantia team to discuss your clinical program through the link below. See at CPHI!
