The Gut Microbiome can influence the outcome of your clinical trial
Why consider the gut microbiome in phase II and III trials?
The gut microbiome plays a central role for the metabolism of many drugs and biological compounds. The gut microbiome influences the bioavailability, toxicity and responsiveness of a patient to a given drug. In return, the profile of a patient’s gut microbiome can predict how the patient respond to a the drug.
This has been demonstrated for a range of compounds, including anti-integrin in IBD, Ustekinumab in Crohn’s and irinotecan in colorectal cancer (1). The efficacy, effectiveness and safety of a drug, as measured during phase II/III trials, can therefore greatly be influenced by the different microbiome profiles the participating patients.
How can a gut microbiome analysis improve the success rate of your clinical trial?
By analyzing the gut microbiome profile of patients in the trial, BiomCare can assess:
- How important the gut microbiome is for drug response,
- Calculate how well the gut microbiome can predict 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 or absorption).
By incorporating the results from BiomCare’s analysis into your trial statistical analysis, you can stratify participants into high and low responders, and 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. You can further benefit from the analysis by incorporating it into later trials, such as a phase III trial by stratifying participants, improving power and success rate. Altogether, incorporating the gut microbiome analysis into your clinical trial holds the potential to facilitate adaptive design, reduce cost and improve success rates.
What BiomCare needs from you?
If you are planning or currently undertaking a clinical trial of a compound that might be influenced by the gut microbiome, we would like to hear from you. Such a drug is likely orally ingested, might depend on or effect the physiological structures, cells, metabolites or hormones that are linked to the gut microbiome. Alternatively, the drug might be known to have variable drug response not explained by human genetics.
If you decide to collaborate with BiomCare we only need two things from you during the trial:
- A stool sample from each study participant before the drug is administered. BiomCare provides you with a stool collection kit that include all instructions and an envelope with return address. After stool collection, the participants simply need to put the kit into the nearest postbox.
- Clinical data on the observed drug response, together with a few additional phenotypic variables such as age, gender and BMI. The data must have an ID that can link the clinical data with the stool samples. BiomCare does not otherwise need person-identifying information.
1) Doherty et al, 2017; Guthrie et al, 2017; Ananthakrishnan et al., 2017; Zimmermann et al., 2019