This Is What Outcome Data Looks Like at Scale.
The numbers behind Flore Clinical — including the limitations, stated plainly.
The three cohorts
Different questions need different denominators. Here are ours.
Formulation cohort
Patients who received a formulation. The basis for tolerability and complaint-rate analysis.
Sequencing cohort
Subjects with microbiome sequencing across 23,000 tests — the input to the engine.
Paired outcome cohort
Subjects with paired pre/post records linking a formulation to symptom resolution over time.
Improvement over time
In real-world follow-up, patient-reported improvement tends to accumulate as patients stay on treatment (651 paired subjects) — described qualitatively, because there is no control arm.
The bars illustrate the general direction of patient-reported improvement over time; they are directional and illustrative only. Because there is no control arm, Flore does not publish condition-level efficacy percentages.
Body systems the data covers
The real-world cohort spans multiple body systems. We describe coverage qualitatively rather than publishing condition-level efficacy percentages.
Many patients present with symptoms across two or more body systems — which is why multi-formula and booster-layered recommendations matter.
Tolerability
Tolerability at this scale matters because formulation complexity rises with patient need. The engine adds strains where the data supports them and holds back where it doesn’t — keeping tolerability high even as complexity climbs.
Limitations, stated plainly
Real-world evidence has boundaries. Here are ours — because trust is built on honesty about them.
No control group
This is observational, real-world data. There is no randomized control arm in this dataset, so resolution rates cannot be attributed to treatment alone.
Self-report
Symptom resolution is patient-reported. It reflects how patients felt and described their symptoms, not an independent clinical adjudication.
Retest selection bias
The paired cohort consists of patients who chose to resample. Those who retest may differ systematically from those who don’t.
Future directions
To move beyond observational evidence, controlled trials are in development for The Regular One (GI) and The Bright One (Mood/Neuro). We’re actively inviting co-investigators, IRB partners, and data-sharing collaborators to scrutinize the methods and help build the controlled evidence base.
The peer-reviewed cornerstone
Our precision-synbiotic approach in the published literature — described accurately.
Phan J, Calvo DC, Nair D, Jain S, Montagne T, Dietsche S, Blanchard K, Treadwell S, Adams J, Krajmalnik-Brown R. “Precision synbiotics increase gut microbiome diversity and improve gastrointestinal symptoms in a pilot open-label study for autism spectrum disorder.” mSystems. 2024;9(5):e00503-24. American Society for Microbiology.
This pilot open-label study reported that precision synbiotics matched to an individual’s gut microbiome increased microbiome diversity and improved gastrointestinal symptoms in participants with autism spectrum disorder. It is a pilot open-label study — not a randomized controlled trial. Controlled trials for The Regular One (GI) and The Bright One (Mood/Neuro) are in development to build the controlled evidence base.
Download the white paper
Full methods, cohort definitions, and analysis behind targeted, outcome-derived formulation.
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