BaseClear offers complete solutions to analyse the interactions between drugs and the microbiota in clinical trials. The microbiota plays an important role in the efficacy, effectiveness and safety of many drugs, probiotics, cosmetics and other biological compounds. The microbiota influences the bioavailability, toxicity and responsiveness of a patient to a given drug. On the other hand, the patient’s microbiota can predict how the patient responds to a drug.

BaseClear can facilitate the entire realm of microbiome-based clinical research, and offers complete solutions to help determine the effect of drugs, probiotics, cosmetics and other biological compounds on the gut and skin microbiota. Our solutions cover the entire process including sampling, storage, logistics, DNA and/or RNA extraction from difficult samples, collection of metadata, downstream bioinformatics, statistical analysis, optional sharing of results with the clinical trial participants and reporting.

BaseClear and CHDR partner in clinical trials

The Center for Human Drug Research (CHDR) in Leiden is collaborating with BaseClear for microbiome analysis of the skin and the gut in the context of clinical trials. “BaseClear is a partner for us in with regard to technical, scientific and logistical aspects. It is a matter of complementary expertise and professional partnership.”

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Microbiome-based clinical research

The efficacy, effectiveness and safety of drugs, as measured during clinical trials, can greatly be influenced by the different microbiome profiles of the participating patients. By analysing the microbiome profile of participants in the clinical trial, you can assess the importance of the microbiome for drug response, predict how the microbiome influences drug response (e.g. separate high, low or non-responders), and identify the microbial features involved in mediating the response, e.g. specific bacteria or enzymes essential for drug metabolism. This helps to understand if efficacy is dependent on microbiome profiles. This can improve your power and confidence in your results and provide further understanding of physiological drug mechanisms.

The importance of sampling, storage and extraction in microbiome analysis

A microbiome analysis has no value if the generated data does not represent the microbial community in the faecal or skin samples from which they were extracted. Especially in clinical trials it is of great importance that the results are reliable and validated. BaseClear has solutions ready for every step.

Things to consider in microbiome-based clinical research:

  • Standardized sampling methods
  • Sample stabilization, during storage and transport
  • Unbiased DNA and/or RNA extraction method
  • Quality control, including microbiome standards

Strain-specific quantification in clinical samples

BaseClear offers strain-specific quantification services based on quantitative real-time PCR (qPCR). With this services we develop strain-specific primers for the detection and quantification of specific microbial strains in complex faecal or skin samples. These strain-specific qPCR assays are suitable for identification and quantification of specific microorganisms in microbiome studies used in clinical trials.

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Experts meeting on microbiome analysis for clinical trials

BaseClear has years of experience in microbiome analysis, including the analysis of interactions between drugs and the microbiota in clinical trials. We routinely organise expert meetings wherein scientists and researchers meet, share and discuss microbiome projects, challenges and opportunities.

Our experts meetings

Meet Radhika Bongoni!

Radhika is our business developer specialised in microbiome analysis and microbial strain characterization for clinical trials and regulatory approval. Radhika received her Ph.D. in Food technology (2014) from Wageningen University (the Netherlands) and an MBA (2015) from Tias School for Business & Society (the Netherlands). With techno-commercial expertise, she is involved in business growth and market penetration by fostering relationships with partners. Prior to BaseClear, Radhika was responsible for establishing dietary supplements market in western Europe, India, South Africa and Russia.

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