Market atlas / Other / Probiotics
Probiotics (gut microbiome)
traditional-to-validatedsupplementgut-microbiome-modulationimmune-modulation● gut-microbiome-diversity
Stage by geography
signalpreclinfirst-in-humanRCTapprovedreal-worldconsumerUSUKCNKR+3 stages
MarketsUS United States FDAUK United Kingdom MHRA / NICECN China NMPAIN India CDSCOJP Japan PMDACH Switzerland SwissmedicSG Singapore HSAIL Israel Ministry of HealthKR South Korea MFDS
What each market approved it for
| Market | Stage | Since | Indication / class / form |
|---|---|---|---|
| US | consumer | not dated | not published |
| UK | signal | not dated | not published |
| CN | RCT | not dated | not published |
| KR | RCT | not dated | not published |
Legal status by market
| Market | Legal class | Effective | Status & source |
|---|---|---|---|
| US | Dietary supplement | not dated | Sold as a US dietary supplement; label on file in the NIH Dietary Supplement Label Database (Align Probiotic (B. longum 35624)). |
Biomarker trends
no biomarker readings yet
Studies
The studies on Probiotics, what they found, in whom and how strongly, are on its evidence page, each linked to its source.
What the trials measure
Registered primary outcomes this development's trials are powered on, commonest first (ClinicalTrials.gov). What is measured, across markets.
| Registered primary endpoint | Markets measuring it |
|---|---|
| Changes in TC and LDL-C | CN |
| AE and SAE | CN |
| One year progression free survival rate | CN |
| Complete response rate at the end of radiotherapy for one month | CN |
| Change in body weight before and after intervention | CN |
| Change in BMI before and after intervention | CN |
| Change in waist-hip ratio (WC) before and after intervention | CN |
| Change in wrist circumference before and after intervention | CN |
| Change in visceral fat area before and after intervention. | CN |
| Change in basal metabolic rate (BMR) before and after intervention | CN |
Connections
no connections yet
Trajectory
2026
Legal statusUS: dietary supplement. Sold as a US dietary supplement; label on file in the NIH Dietary Supplement Label Database (Align Probiotic (B. longum 35624)).
DSLD:278084 · machine-extracted
Get into the weeds: raw observations + provenance
legal__US__otc_probiotics 2026-09-28 kind=legal_status verify=M otc_probiotics in US: dietary-supplement (Sold as a US dietary supplement; label on file in the NIH Dietary Supplement Label Database (Align Probiotic (B. longum 35624)).) source DSLD:278084 https://dsld.od.nih.gov/label/278084 probiotics_facets 2026-09-28 kind=facets verify=M Probiotics (gut microbiome) facets (mechanism tags pending curator review) source NCT03080818 https://clinicaltrials.gov/study/NCT03080818 probiotics_us 2026-09-28 kind=geography_stage verify=M Probiotics is sold in the US as a dietary supplement (Align Probiotic (B. longum 35624)) source DSLD:278084 https://dsld.od.nih.gov/label/278084 ctsearch__CN__otc_probiotics 2026-09-29 kind=geography_stage verify=M probiotic: 7 registered trial(s) in CN, highest phase 2 [NCT06943235] source NCT06943235 https://clinicaltrials.gov/study/NCT06943235 ctsearch__KR__otc_probiotics 2026-09-29 kind=geography_stage verify=M probiotic: 1 registered trial(s) in KR, highest phase 3 [NCT05604989] source NCT05604989 https://clinicaltrials.gov/study/NCT05604989 ctsearch__UK__otc_probiotics 2026-09-29 kind=geography_stage verify=M probiotic: 2 registered trial(s) in UK, highest phase ? [NCT05588674] source NCT05588674 https://clinicaltrials.gov/study/NCT05588674 ctsearch__US__otc_probiotics 2026-09-29 kind=geography_stage verify=M probiotic: 7 registered trial(s) in US, highest phase 3 [NCT01268618] source NCT01268618 https://clinicaltrials.gov/study/NCT01268618