A Pilot With Purpose: Koralo’s Human Study in Action

Koralo is currently enrolled in the Alethios Early Stage Program — and their study is already in full swing.

For Guido Albanese, cofounder of Koralo, generating human evidence wasn’t a future milestone. It was foundational. From the beginning, Koralo set out to build products rooted in measurable impact — not just positioning.

Founded on the belief that everyday foods can become natural health boosts, Koralo is developing solutions designed to improve wellbeing through gut health. But as Guido puts it, conviction alone isn’t enough:

“We are a data-driven start-up: Human clinical evidence helps us identify where we can make a difference in people’s lives and shape our product applications accordingly to have the maximum positive impact.”

To generate that evidence, Koralo is running a two-arm interventional, open-label study designed as a signal-seeking pilot. The goal isn’t to run the largest possible trial out of the gate. It’s to identify early signal, refine hypotheses, and use those insights to design a more targeted, higher-powered study next.

A Hybrid Approach That Fits a Startup

Koralo chose a hybrid model: maintaining their own internal Principal Investigator while leveraging Alethios for platform infrastructure, recruitment, and operational execution.

That balance allowed them to maintain scientific oversight internally while avoiding the delays and overhead of traditional clinical infrastructure.

“Alethios was there all the way helping us navigate, from the regulatory framework of running a clinical study to helping us with their critical thinking and practical advice how to design a study fit to the stage we are at.”

For Guido and his team, one of the biggest surprises was how quickly the study came together.

“First the ease and speed of setting up the study focusing on content rather than the process.”

Instead of getting lost in bureaucracy, Koralo was able to focus on study design and hypothesis refinement — exactly where early-stage teams should be spending their energy.

Enrollment Ahead of Schedule

Recruitment is often where early studies stall.

Koralo’s study targets participants experiencing GI discomfort — a clearly defined population. Through the Alethiad participant network, enrollment moved quickly, and enrollment is on track to finish ahead of schedule.

For an early-stage team running its first structured human study, that speed matters. It shortens feedback loops. It accelerates learning. And it builds internal confidence.

More importantly, it validates the feasibility of the next, more targeted trial. The data collected will inform how Koralo designs its next trial — potentially with tighter endpoints, refined inclusion criteria, and more objective measures. That progression — from early signal to smarter second study — is exactly what the Early Stage Program is built to support.

Advice to Other Early-Stage Founders

When asked what he would tell another early-stage founder considering running their first human study, Guido didn’t hesitate:

“Get a partner like Alethios, who understands the challenges of a start-up and helps you hands-on to build by adjusting to your processes rather than the other way around.”

That perspective captures a core principle of the Early Stage Program, If you’re an entrepreneur, researcher, or innovator in human health—and you’re ready to run a real study—we’d love to hear from you.

Apply to the Alethios Early stage Program

You can read the full interview here.