Evidence Base

The record.

Published research behind Flore Clinical, and the translational-science record of the team that built it.

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Published research

Authored by the scientific team at Sun Genomics, Inc. (now Flore Clinical) in mSystems, the American Society for Microbiology's open-access journal.

Autism · 2024

Precision synbiotics in autism spectrum disorder

Phan J, Calvo DC, Nair D, Jain S, Montagne T, Dietsche S, Blanchard K, Treadwell S, Adams J, Krajmalnik-Brown R.

PubMed 38661344  ·  doi:10.1128/msystems.00503-24

Collaboration with Arizona State University's Biodesign Center for Health Through Microbiomes.

IBS · 2021

Gut microbiome alterations in irritable bowel syndrome

Phan J, Nair D, Jain S, Montagne T, Flores DV, Nguyen A, Dietsche S, Gombar S, Cotter P.

PubMed 34726487  ·  doi:10.1128/mSystems.01215-21

Collaboration with Paul Cotter (APC Microbiome Ireland / Teagasc Food Research Centre).

Real-world GI resolution curve

Beyond the published trials, Flore tracks patient-reported symptoms within its own paired real-world cohort as each formulation is iterated against repeat sequencing. These are real-world, observational signals, not a controlled trial — and because there is no control arm, Flore does not publish condition-level efficacy percentages.

Gastrointestinal · paired cohort (n=651)

Patients report improvement as formulas iterate

In the paired GI cohort (n=651), many patients report that their symptoms improve across successive formulation cycles, and repeat sequencing can show measurable microbiome change over time. Because this is observational data with no control arm, these are directional real-world signals — hypothesis-generating, not proof of efficacy — so we describe the trajectory qualitatively rather than publishing condition-level resolution percentages.

Follow-up interval Patient-reported trend
First interval (<6 months) Many patients report early symptom improvement
Later in the course (~20 months) Improvement is often sustained or greater as formulas iterate

Signals are drawn from a paired real-world cohort tracked across ~6.6-month median intervals and followed longitudinally out to 20 months. Because the dataset has no control arm, Flore does not publish condition-level efficacy percentages; these patient-reported observations are hypothesis-generating and do not establish efficacy. Real-world evidence, not a controlled trial. No statement here is a disease claim.

Founder's translational-science record

Peer-reviewed publications by Craig J. Rouskey, MSc (ORCID 0009-0001-6794-5346) preceding the microbiome focus.

Cancer Research · 2013

Durable adoptive immunotherapy for leukemia

Berrien-Elliott MM, Jackson SR, Meyer JM, Rouskey CJ, Nguyen TL, Yagita H, Greenberg PD, DiPaolo RJ, Teague RM.

PubMed 23188506  ·  doi:10.1158/0008-5472.CAN-12-2179

Performed at Saint Louis University School of Medicine, Department of Molecular Microbiology and Immunology, under Ryan M. Teague. Collaborating co-author: Philip D. Greenberg (Fred Hutchinson Cancer Center).

Vaccine · 2007

Recombinant Peru-15 cholera toxin B vaccine against enterotoxigenic E. coli

Roland KL, Cloninger C, Kochi SK, Thomas LJ, Tinge SA, Rouskey C, Killeen KP.

PubMed 18045752  ·  doi:10.1016/j.vaccine.2007.09.074

AVant Immunotherapeutics, Needham, MA.

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