Probiotics Clinical Trials

Scientific Background

The WHO defines Probiotics as live microorganisms which when administered in adequate amounts confer a health benefit on the host. Probiotic bacteria are extensively integrated in food production, generally the bacteria belonging to the genera Lactobacillus and Bifidobacterium, although other genera such as Escherichia, Enterococcus, Streptococcus, and Saccharomyces have also been marketed as probiotics. The health benefits most commonly associated to probiotics have been to maintain a healthy microbiota or to improve its resilience, i.e. to preserve the gut microbiota balance and the defences against pathogens.  Specific probiotics may also provide other important health benefits such as desirable lactose intolerance modulation, gastrointestinal comfort (bowel function, diarrhea prevention or symptom alleviation, among others), immune response regulation, food allergy prevention, blood cholesterol reduction, vitamin synthesis or anti-carcinogenesis and anti-bacterial activities. 

The term Prebiotic has been defined as a non-viable food component that confers a health benefit on the host associated with modulation of the microbiota according to the FAO. Carbohydrate substrates (e.g. dietary fiber) are widely used as prebiotics due to their capacity to promote the components of the intestinal microflora. Certain dietary components are resistant to digestive enzymes hydrolysis which avoid them to be absorbed in the gastrointestinal tract.

When probiotics and prebiotics are combined, they provide a synergistic health benefit for the host, being the product of this combination known as Synbiotics. A synbiotic is a product containing probiotic and prebiotic in which the prebiotic compound specifically favours the probiotic compound.

For food production, probiotics have been used in dairy products, however latest studies reveal that other novel probiotics are better and superior carriers for the delivery of probiotics. Food regulatory institutions such as EFSA and FDA require scientific evidence when associating a health claim to a probiotics, prebiotics or synbiotics product. The evidences need to be obtained through human interventional studies, that need to be designed following the guidance provided by these institutions. The main requirements of the study outcomes are the characterization of the strain, the identification of the health benefit for a specific target population and the demonstration of the same in a normal healthy target population.

What Atlantia offer

Atlantia, in collaboration with our academic partner, the Alimentary Pharmabiotic Centre (independently ranked #1 in the world for research in anti-microbials and therapeutic microbes by Thomson Reuters Science) Reuters), has developed a “whole solution” for client companies to assist in getting a positive EFSA response. Atlantia Staff have extensive experience in carrying out clinical trials with probiotics in health areas such as GI discomfort, constipation, IBS, sports, nutrition, stress etc. Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their investigational product(s), agreeing and applying the most suitable measurements/ end-points and statistically powering studies to ensure that study objectives are achieved and reported. Frequently companies lack the in-house expertise to dissect and understand clinical results.

We work in partnership with our clients at all stages of the clinical study, including regulatory submissions, ethical approvals and publication in peer reviewed academic journals.

Measurements & Indications

Probiotics measurements
Endpoints/ measurements
Shotgun Metagenomic Sequencing De Novo Sequencing of Genomes 16S rRNA sequencing, Re-Sequencing of Genomic Fragments Functional Genomics
16S rRNA sequencing, Re-Sequencing of Genomic Fragments Functional Genomics Flow Cytometry & Fluorescence Activated Cell Sorting (FACS) Metabolomics / Lipidomics/ Proteomics/ Functional Genomics/ Transcriptomics
Probiotic viability and efficacy in GI tract Standard & Custom Library Generation Fatty Acid / Bile Acid Analysis
Microbial bioactive screening and identification PCR Probiotic viability and efficacy in GI tract
Other measurements depending on the specific desired health claim    

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Check our Resources on Probiotics Expertise