Gut microbiome plays a significant role in human health, nutrition and development. The microbiome represents a community of around 100 trillion micro-organisms including, bacteria, viruses, fungi and protozoa.1
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A wide range of products are available on a commercial basis to improve the health of the gut microbiome, with the market for these products anticipated to reach USD 1,598 million by 2028.2 These products serve a wide range of purposes, including prebiotics, probiotics and therapeutic treatments.
Designing microbiome-based product trials
Before these products can be used, they must be thoroughly tested to confirm their safety, efficacy and applicability.
A typical microbiome-based product trial begins by defining the objectives of the trial and the product in question. This may include primary and secondary objectives; a trial may be looking to verify a specific outcome or product result, or it may be more exploratory.
Outlining the scope and desired results of the trial will generally involve considerations around its endpoint, how the results will be measured and what tools or metrics will be involved during these measurements.
It is necessary to define the population of interest, outlining any specific inclusion or exclusion criteria. For example, a trial may seek to work with a healthy population or a population of individuals with a particular medical condition or physiological trait.
Delivering the trial
Once the trial has been developed, a team of research coordinators and assistants will typically collaborate with the trial’s project manager to begin the process of delivering the trial. Participants are recruited and screened, and the intervention is provided – a process that can take weeks to months, depending on the product that is being trialed.
Depending on the scope and goals of a trial, this may involve participants having their blood drawn for analysis, data collected via questionnaires or interviews or other forms of physiological assessment. Participants may be asked about signs or symptoms of a current medical issue or about their general feeling, quality of life or mood.
It is important to note that many studies will be looking for clinically significant changes first and foremost, for example, a measurable impact on blood pressure or another observable alleviation of certain symptoms.
These steps may be repeated over a number of visits to track any changes in the particular criteria being assessed, as defined in the trial design. Once the allotted visits have been completed, and all required data has been acquired, a close-out visit will be done with each participant to end the process formally.
To ensure quality and accountability, the study is monitored by a clinical research associate whose role is to confirm that all steps are followed diligently and that reports are entered and collated correctly.
Cleaning and analyzing trial data
Once the final participant’s last visit is completed, all collected data must be cleaned to ensure that it is valid, accurate and of sufficiently high quality.
At this point, participants will be allocated into populations; for example, the population with the intention to treat, also known as the ‘full analysis set.’ This population best represents the ‘real world’ population because it includes people who have stopped taking the product partway through the trial or have taken the product inconsistently.
A blinded data review is completed by a committee, typically comprised of a statistician, a clinician, the principal investigator and possibly a representative of the study’s sponsor.
This committee is responsible for deciding how the ‘intention to treat’ population is defined, which participants’ results may be excluded from ongoing data analysis and how any outliers or extreme results are to be dealt with.
The primary goal of this data cleaning process is to ensure the generalizability of results based on how people are likely to use the product in their daily lives. Once participants have been allocated into populations and the data has been cleaned, the database is locked, and statistics are generated.
It is typically the principal investigator and their clinical team that will be responsible for evaluating these results.
Microbiome-based products and the wider clinical trials landscape
Research into the microbiome continues to evolve. Many studies are currently focused on either alpha diversity – evaluating a change in a single community or sample - or beta diversity – evaluating a change in multiple communities or samples3 – though other ways of investigating changes in the microbiome are being developed all the time.
There are also several publicly available databases of microbiome data, meaning that studies into shifts in a population can be compared with a range of existing data to further validate or corroborate products’ effects on the microbiome.
This is important, but because sponsors seek approval by the FDA or an equivalent organization, they must meet stringent standards around product safety and efficacy.
Regulatory bodies are also placing increasing emphasis on data integrity, data quality and data management methods, meaning that this must meet all accepted international and national guidelines on good practice.
The importance of clinical trials expertise
One of the most straightforward means of ensuring that trials for microbiome-based products are designed, delivered and analyzed in line with all appropriate regulatory frameworks and best practice guidance and that results are relevant is to work with an established external provider.
Atlantia Clinical Trials has over a decade of experience in the provision of human clinical studies. The company is dedicated to delivering clinical results on time and on budget, leveraging the most up-to-date scientific methods while ensuring that transparency, participant care and cost-effectiveness remain central to every study.
References
- Valdes A M, Walter J, Segal E, Spector T D. Role of the gut microbiota in nutrition and health BMJ 2018; 361 :k2179 doi:10.1136/bmj.k2179
- Markets and Markets. Human Microbiome Market by Product (Prebiotics, Probiotics, Food, Diagnostic Tests, Drugs), Application (Therapeutic, Diagnostic), Disease (Infectious, Metabolic/Endocrine), Research Technology (Genomics, Proteomics, Metabolomics) - Global Forecast to 2028. 2021. https://www.marketsandmarkets.com/Market-Reports/human-microbiome-market-37621904.html
- Wagner, B., Grunwald, G., Zerbe, G., Mikulich-Gilbertson, S., Robertson, C., Zemanick, E. and Harris, J., 2021. On the Use of Diversity Measures in Longitudinal Sequencing Studies of Microbial Communities.
About Atlantia Clinical Trials
Atlantia Clinical Trials Ltd is a CRO that specializes in conducting studies in foods, beverages and supplements for companies world-wide that want to scientifically validate their functional ingredients to support an: EFSA (European Food Safety Authority) Health Claim; FDA (Food & Drug Administration) Structure Function Claim; or General Product Marketing Claim.
Atlantia works with world leading scientists (among the top cited 1% internationally, in the areas of digestive health and functional foods) at the: APC Microbiome Institute in University College Cork, Ireland; Teagasc, Moorepark, Ireland and recognized centers of excellence globally.
Atlantia runs and operates its own clinic sites and conducts all studies to ICH-GCP standard (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice). Its team includes physician experts in digestive health, mental health (psychological stress and cognition), cardiovascular health, sports performance, metabolic disease, bone health, immune health and healthy ageing. The clinical team also includes project managers, research nurses, nutritionists, certified sports trainers and lab researchers.
Atlantia manages all elements from protocol design, placebo manufacture, recruitment, and study execution, to sample and data analysis, statistics and report/dossier preparation to provide a service which is technically, scientifically and clinically superior.
The clinical studies cover a broad spectrum of functional food and beverage categories, such as dairy, cereal, probiotic, different protein forms, infant-specific foods, vitamins/minerals, plant or marine extracts and medical foods.
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