Real-World Evidence

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.

18,392

Formulation cohort

Patients who received a formulation. The basis for tolerability and complaint-rate analysis.

14,704

Sequencing cohort

Subjects with microbiome sequencing across 24,193 tests — the input to the engine.

651

Paired outcome cohort

Subjects with paired pre/post records linking a formulation to symptom resolution over time.

Cumulative symptom resolution

Within-subject resolution accumulates as patients stay on treatment (651 paired subjects).

47.4%
T1 · first follow-up (~6.6 mo)
~64%
T2 · continued follow-up
~78%
T3 · later follow-up
92%+
T4 · cumulative by ~20 mo

T1 (47.4%) and the ~20-month cumulative figure (92%+) are measured; intermediate T2/T3 points are illustrative of the cumulative trajectory between them.

Resolution by body system

First-follow-up within-subject resolution rates.

Depression65.0%
Irritable bowel syndrome (IBS)64.7%
Chronic inflammation64.3%
Anxiety45.2%

20.4% of patients present with symptoms across two or more body systems — which is why multi-formula and booster-layered recommendations matter.

Tolerability

4.87%
complaint rate across 18,392 patients
68
curated strains drawn on — complexity matched to need

A low complaint rate 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, randomized controlled trials are underway 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.

Become a peer reviewer / partner →

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. Randomized controlled trials for The Regular One (GI) and The Bright One (Mood/Neuro) are currently underway to build the controlled evidence base.

DOI: 10.1128/msystems.00503-24 → PubMed (PMID 38661344) →

Download the white paper

Full methods, cohort definitions, and analysis behind targeted probiotic efficacy.

Read the white paper →
These statements have not been evaluated by the Food and Drug Administration. GoodOnes™ products are not intended to diagnose, treat, cure, or prevent any disease. Real-world evidence is observational and uncontrolled.