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Microbiome Clinical Trials

Scientific Background

Microbiome refers to the collective genomes of the microorganisms in a particular environment, and microbiota is the community of microorganisms themselves.

The human microbiome is elaborate and dynamic. Our bodies are teeming with microbiota which can be found in and on our body; skin, blood, vagina and predominantly, the gastrointestinal tract. There are more than >150 times more microbial genes than mammalian genes with the microbiome often considered a virtual ‘’organ” of the human body. The microbiome influences many areas of human health ranging from innate immunity to chronic health conditions such as obesity and diabetes, to neurological diseases such as Parkinson’s and psychiatric disorders such as depression and anxiety. In addition, the microbiome may be seen as the only “organ” that can be altered without surgery. It is not surprising, therefore, that there is growing interest in pursuing ways to treat or reduce the risk of disease by altering the microbiome. There are multiple approaches that are proposed to alter the microbiome including (but not limited to) probiotics, prebiotics, diet-based therapies, and faecal transplantation. Assessment of these approaches requires both pre-clinical and clinical studies, likely to involve both animal model system and well-designed clinical trials.

What Atlantia offer

As a spin out of the APC Microbiome Ireland, Atlantia Food Clinical Trials has extensive experience in conducting microbiome-related clinical studies We provide our clients with state-of-the-art microbiome research through all stages of the clinical trial process from design and conduct of the trial right through to the final report.

We conduct extensive microbiome sampling and analysis including 16S and shotgun sequencing, metabolomics and bioinformatics.

We have conducted trials on a variety of investigational food products (IP), ranging from probiotics, prebiotics, fibers and a range of other substrates, including botanical extracts, minerals, vitamins and peptides.

We have a large database of healthy subjects striated across gender and age, and also a considerable patient database (IBS/IBD).

Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their IP, agreeing and applying the most suitable diagnostics. We can statistically power your study to ensure that your objectives are achieved and reported in accordance with EFSA  and FDA guidelines.

Measurements & Indications

Microbiome Analysis
Shotgun Metagenomic Sequencing De Novo Sequencing of Genomes Flow Cytometry & Fluorescence Activated Cell Sorting (FACS)
16S rRNA sequencing Re-Sequencing of Genomic Fragments Metabolomics / Lipidomics
Transcriptomics Standard & Custom Library Generation Fatty Acid / Bile Acid Analysis
Functional Genomics PCR Proteomics

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Learn more

Check our Resources on Probiotics in Transition