Clinical
Claims Studies
Validate microbiome impact with the rigor and speed to stand behind every claim. Evidence backed by biology, not assumptions.
Clinically Proven. Microbiome Certified
HelloBiome’s Clinical Claims Studies generate rigorous, in vivo microbiome evidence — measured on real people, in real conditions — and deliver claims-ready outputs without the timelines of traditional studies. Studies can be run at home, in clinic, or embedded into CRO-led trials. Qualifying products earn the HelloBiome Microbiome Seal — a mark of clinically validated microbiome performance.
Turn Product Promises into Biological Proof
HelloBiome’s Clinical Claims Studies generate rigorous, in vivo microbiome evidence — measured on real people, in real conditions — and deliver claims-ready outputs without the timelines of traditional studies. Studies can be run at home, in clinic, or embedded into CRO-led trials. Qualifying products earn the HelloBiome Microbiome Seal — a mark of clinically validated microbiome performance.
Microbiome analysis
and report delivered
in days
Flexible study
design – remote,
in-clinic, or CRO-led
CLIA/CAP-accredited laboratory
standards
HelloBiome Microbiome Seal awarded to qualifying products
How Clinical Claims Studies Work
From study design to claims-ready outputs — in as little as three days.
1. Design
Study Design
We build a study protocol around your ingredient or formulation — including IRB review when applicable — so every result is scientifically and ethically defensible from the start.
2. Recruit
Targeted recruitment
and at-home sampling
Participants are selected to match your target consumer profile — ensuring results reflect the real people your product is designed for.
3. Collect
At-Home Sampling
and Consumer Perception Data
In vivo samples are collected through decentralized protocols — at home, in clinic, or within an existing CRO-led study — with no disruption to current workflows.
4. Analyze
Advanced sequencing and analysis
We analyze bacteria and fungi at the species level across the full microbiome — turning raw biological data into clear, interpretable results.
5. Claim
Claim-ready report, certification & seal
You receive claims-ready datasets, reporting, and the evidence needed to support product positioning across regulatory, retail, and consumer channels in just a few days. Depending on your results, you may also receive the official HelloBiome seal as well to market your products.
What You Walk Away With
Claims-ready datasets and reports
Strategic microbiome insights for smarter product decisions
The HelloBiome Seal and digital certification
The HelloBiome Difference
Not all microbiome science is created equal. HelloBiome sets the standard for microbiome intelligence, combining certified, clinical-grade rigor with an AI-enabled intelligence platform — giving teams deeper biological insight, repeatable standards, and a faster path from data to decision.
Certified,
Clinical-Grade Foundations
HelloBiome operates within CLIA- and CAP-accredited laboratory workflows, holding microbiome data to the highest standards for accuracy, reproducibility, and scientific credibility — so every output is defensible from day one.
Deeper
Biological Insight
We go beyond identifying which microbes are present. HelloBiome’s proprietary scoring models measure microbiome balance, stability, and functional shifts — giving teams a more complete, biologically meaningful picture of how products affect the microbiome.
A Growing
Intelligence Ecosystem
Data generated today strengthens the platform over time—training AI-driven models that support future insights, validation, and predictive development.
Seamless Integration & Faster Insights
Whether you’re embedding microbiome endpoints into a CRO-led study or adding biological validation to an in-house pipeline, we integrate seamlessly into existing workflows. Our sequencing and microbiome analysis deliver structured insights in days, not months.
Join the Leaders in Microbiome-Validated Skincare
The HelloBiome Microbiome Seal is awarded to products that demonstrate measurable microbiome impact in Clinical Claims Studies. Explore the companies already bringing microbiome-validated innovation to market.
Start your validation journey
Let’s turn your product promise into biological certainty with rigorous microbiome science.