The Gut Microbiome Gold Rush: Why Experts Are Pumping the Brakes

Just over a year ago, an international panel of 69 experts published a landmark consensus statement in The Lancet Gastroenterology & Hepatology, and their message was clear: we need to put the brakes on the commercial microbiome testing free-for-all before it does more harm than good.

Why This is Still a Problem in 2026

The lack of regulation and standardisation in microbiome testing isn't just an academic concern. It could result in considerable waste of individual and healthcare resources and potential drawbacks in clinical management of patients. In other words, people are spending money on tests that might lead them to make unhelpful or even harmful health decisions.

What the Experts Recommend

The international consensus establishes a comprehensive framework covering everything from who should prescribe these tests to how results should be reported. Here are the key takeaways:

Who Can Prescribe

Microbiome tests should only be prescribed by licensed healthcare providers such as physicians, pharmacists, and dietitians

Quality Standards Matter

Laboratories commercialising microbiome tests must adhere to high-quality standards and involve experts from different disciplines with gut microbiome expertise.

The Testing Process

The consensus provides detailed guidance on the entire testing process:

  • Before testing, further clinical data should be collected, including age and current medications.
  • Collection and storage protocols matter enormously for result accuracy.
  • Gut microbiome profiling should use amplicon sequencing (like 16S rRNA) or whole-genome sequencing.

The Ethnic Diversity Challenge

Emerging research shows that vaginal microbiome profiles exhibit ethnic variability, and the same is likely true for gut microbiomes. This means that standardised reference ranges and benchmarks need to account for population diversity.

The Direct-to-Consumer Dilemma

When consumers receive inconsistent or inaccurate results, they may make dietary changes, stop taking medications, or pursue unnecessary treatments. Reports to consumers should avoid deterministic language, communicate uncertainty clearly, and link advice to evidence-based dietary patterns rather than opaque "scores."

What Needs to Happen Next

Professor Antonio Gasbarrini emphasises that this consensus document marks a decisive step toward indispensable standardisation. But several challenges remain:

  1. Education
  2. Research
  3. Regulation
  4. Standardisation

The Bottom Line

If you're considering a direct-to-consumer microbiome test, here's what you should know:

  • Be skeptical of sweeping claims
  • Context matters
  • Talk to your doctor
  • Don't make major health decisions based solely on test results:

Want to find out more? Join our course, Microbiomics in Clinical Trials, led by Nikolaj Sørensen of Clinical Microbiomics, by clicking here.

The international consensus statement was published in The Lancet Gastroenterology & Hepatology in December 2024, representing collaboration among 69 experts from multiple countries and disciplines, including clinicians, microbiologists, microbial ecologists, and computational biologists.

 

Published on Jan 27, 2026 by Ella Thomas