Holobiome and Radicle Science Launch U.S. History’s Largest Mental Wellness Trial Targeting the Gut-Brain Axis

The GUT-FEELINGS p og am, fu ded by ARPA-H, will ide tify eadily deployable o -p esc iptio solutio s fo me tal well ess while also c eati g a u p ecede ted i te ve tio al dataset f om ove 6,000 Ame ica s to suppo t mappi g the gut-b ai axis

BOSTON a d SAN DIEGO, Oct. 08, 2026 (GLOBE NEWSWIRE) — Holobiome a d Radicle Scie ce today a ou ced the lau ch of GUT-FEELINGS, a la dma k two-yea esea ch i itiative backed by a awa d f om the Adva ced Resea ch P ojects Age cy fo Health (ARPA-H), a age cy withi the U.S. Depa tme t of Health a d Huma Se vices. The study will e oll ove 6,000 dive se Ame ica s i two waves a d test 19 eadily deployable p op ieta y food-de ived p ebiotic fo mulas agai st placebo to dete mi e which ca imp ove feeli gs of a xiety a d elated me tal well ess outcomes—a d i which populatio s—with i itial esults expected i the seco d half of 2027.

The scale a d desig of GUT-FEELINGS set a ew sta da d fo i te ve tio al esea ch – combi i g a tech-e abled, a domized, placebo-co t olled dece t alized desig with 19 p ebiotic i te ve tio s, mo e tha 6,000 dive se citize scie tists, a d the collectio a d a alysis of ove 24,000 fecal samples a d 12,000 blood samples.

The 16-week, 20-a m study will a domize pa ticipa ts expe ie ci g feeli gs of a xiety to eceive o e of 19 disti ct p ebiotic fo mulatio s o placebo. The teams will assess validated measu es of feeli gs of a xiety alo gside st ess, mood, sleep, quality of life, flou ishi g, weight a d waist measu eme ts, a d diet quality. These pa ticipa t- epo ted outcomes will be pai ed with deep biological a d digital data, spa i g ult a-deep fecal mic obiome seque ci g a d metabolomics, blood p oteomics, wea able data, facial sca s, a d co ti uous glucose mo ito i g.

Combi ed, these ich data st eams will b oadly suppo t Holobiome’s effo t to build a fou datio model of the huma gut mic obiome – Me cato – which will be used to u de sta d how the gut mic obiome i te faces with biology eleva t fo me tal well ess a d beyo d, as well as i fo m p obiotic a d p ebiotic developme t.

GUT-FEELINGS will co duct igo ous huma esea ch p io to p oduct lau ch a d apply a high-th oughput, pa allel app oach to evide ce ge e atio . I stead of adva ci g o e i te ve tio at a time th ough a li ea p ocess, the study evaluates 19 i te ve tio s i pa allel ac oss two waves to u cove which o es wo k, a d fo whom. This app oach is e abled by Radicle Scie ce’s pate ted Reflexive T ials™ platfo m, which o chest ates a d automates complex, multi-a m, multi-omic t ials at atio al scale a d feeds esulti g huma evide ce di ectly back i to R&D, fo mulatio , egulato y, a d ma keti g effo ts. This ca d amatically comp ess a d de- isk the i ovatio cycle: a si gle t ial ca ide tify the st o gest ca didates to adva ce, substa tiate complia t health claims, eveal espo de subpopulatio s, su face o obvious i sights that may suppo t pate t fili gs, a d ge e ate data to i fo m ext-ge e atio fo mulatio s.

A vast majo ity of food a d well ess b a ds each the ma ket without cli ical t ials o thei fo mulas, a d whe t ials a e co ducted, they a e ofte t eated as a fi al checkpoi t at the e d of the i ovatio cycle. He e, huma esea ch becomes the e gi e fo i ovatio , accele ati g a d de- iski g the path f om hypothesis to huma evide ce to p ove , p ecisio health i te ve tio s i the ma ket.

The implicatio s exte d well beyo d this study. GUT-FEELINGS will also demo st ate how it is ow possible to combi e la ge-scale citize scie ce, co ve ie t dece t alized pa ticipatio , AI age ts, gold sta da d i te ve tio al t ial desig , a d at-home biological sampli g a d digital measu eme t. The esult is a ovel, apid, epeatable model fo ge e ati g igo ous evide ce o o -pha maceutical health i te ve tio s ac oss la ge, dive se populatio s—without the busi ess model co st ai ts o budgets of pha maceutical d ug developme t.

The collabo atio is o ly possible th ough the combi atio of two cutti g edge, compleme ta y platfo ms a d datasets. Holobiome’s mic obiome discove y platfo m is built a ou d its Mic obiome Vault (the wo ld’s most dive se collectio of huma gut bacte ia), its high-th oughput huma gut-simulato , a d a p op ieta y database mappi g mo e tha 120,000 huma metage omes to specific health states. Radicle Scie ce b i gs its pate ted eflexive t ials platfo m, atio wide commu ity of citize -scie tists, ve tically i teg ated esea ch ope atio s, a d p op ieta y cli ical dataset f om Radicle’s food a d well ess t ials o ea ly 100,000 Ame ica s (wo ld’s la gest such dataset).

GUT-FEELINGS is pa t of ARPA-H’s Evide ce-Based Validatio & I ovatio fo Rapid The apeutics i Behavio al Health i itiative (EVIDENT), which is focused o fi di g objective measu es of me tal health a d well-bei g.

PERSPECTIVES ON WHY GUT-FEELINGS MATTERS

Philip St a dwitz, PhDCEO a d Co-fou de , Holobiome“The huma mic obiome matte s fo so ma y aspects of ou health, i cludi g me tal well ess, but we do ot yet have the data o the tools to b i g its p omise to the wo ld. The missi g li k is la ge-scale multimodal data f om i te ve tio al studies, the ki d this t ial is desig ed to ge e ate. We a e so excited to lau ch this i itiative, which p ovides a scalable f amewo k we ca apply time a d time agai .”

Peli Tho ogood a d Jeff Che , MD, MBACo-fou de s, Radicle Scie ce“Cli ical esea ch has t aditio ally bee used to validate p oducts afte they a e developed. We built Radicle to i ve t that model—usi g igo ous huma evide ce ea lie to catalyze discove y, optimize fo mulatio s a d accele ate the path to p ove , p ecisio i te ve tio s. GUT-FEELINGS b i gs that visio to life at a scale eve befo e possible. It is ot simply a la dma k study; it is a bluep i t fo evide ce-fi st health i ovatio .”

Jo atha E. Fieldi g, MD, MPH, MBADisti guished P ofesso , UCLA; fo me Di ecto a d Health Office , Los A geles Cou ty Depa tme t of Public Health“O e of the g eat challe ges i public health is ide tifyi g i te ve tio s that a e ot o ly effective, but p actical a d b oadly accessible. GUT-FEELINGS ca help establish whethe food-based app oaches ca mea i gfully imp ove me tal well ess ac oss a dive se populatio .”

Jo atha D. Ketcham, PhDP ofesso , A izo a State U ive sity; Health Eco omist; Radicle Scie ce Adviso y Boa d“Health i ovatio c eates the g eatest value whe mea i gful outcomes a d b oad accessibility coexist. GUT-FEELINGS ca help establish whe e food-based i te ve tio s ca have the g eatest impact—a d build the evide ce eeded to u de sta d how imp oved health outcomes ca t a slate i to eco omic value fo i dividuals, employe s a d health systems.”

This esea ch was, i pa t, fu ded by the Adva ced Resea ch P ojects Age cy fo Health (ARPA-H). The views a d co clusio s co tai ed i this docume t a e those of the autho s a d should ot be i te p eted as ep ese ti g the official policies, eithe exp essed o implied, of the U ited States Gove me t.

ABOUT HOLOBIOME

Holobiome is a biotech ology compa y ha essi g the pote tial of the huma gut mic obiome to ge e ate p oducts fo co sume , food, a d pha maceutical ma kets. The Holobiome platfo m is a lab-i -the-loop system that combi es la ge-scale huma data with wet-lab expe ime ts. It is powe ed by its Mic obiome Vault (the wo ld’s most dive se collectio of huma gut bacte ia), its high-th oughput huma gut-simulato , a d a p op ieta y database mappi g mo e tha 120,000 huma metage omes to specific health states. Me cato , its developi g fou datio model of the huma gut mic obiome, lea s f om this data, guides expe ime ts i the lab, a d i fo ms p oduct developme t. I te ve tio al expe ime ts, f om the gut simulato to la ge-scale huma t ials such as GUT-FEELINGS, a e desig ed to feed esults back i to the model.

Holobiome’s i itial focus is o the gut-b ai axis, with p og ams i mood, a xiety, st ess, a d pai . Th ough its pa t e ship model, Holobiome is adva ci g mic obiome p og ams with co sume , food, a d pha maceutical pa t e s. Holobiome has bee suppo ted by a wo ld-class i vesto base a d o -dilutive fu di g f om ARPA-H, the NIH, a d the T a slatio al Resea ch I stitute fo Space Health (TRISH). It is headqua te ed i Bosto , Massachusetts.www.holobiome.o g

ABOUT RADICLE SCIENCE

Radicle Scie ce is a healthtech compa y buildi g the evide ce a d i ovatio i f ast uctu e fo p ove , p ecisio well ess. Its pate ted Reflexive T ials™ platfo m powe s Radicle’s P oof-as-a-Se vice™ model, combi i g AI, citize scie ce a d la ge-scale dece t alized cli ical t ials to ge e ate igo ous evide ce with u p ecede ted speed, scale a d p ecisio .

Si ce 2021, Radicle has co ducted placebo-co t olled esea ch i volvi g ea ly 100,000 dive se Ame ica s ac oss all 50 states. By movi g huma evide ce ea lie i the i ovatio cycle, Radicle helps catalyze discove y a d accele ate the developme t of p ove , p ecisio i te ve tio s.

Radicle Scie ce has bee ecog ized as a Fast Compa y Wo ld Cha gi g Idea a d amed to the I c. 5000 fo two co secutive yea s.www. adiclescie ce.com

Media Co tacts:

Holobiome: Jo atha K ive, jo atha @holobiome.o g, 857-244-1633Radicle Scie ce: Heathe G a ato, heathe .g a ato@ adiclescie ce.com, 480-390-4327