Synbiotic SBD111 tolerability RCT in healthy adults, USA
93 stool samples from healthy adults in Massachusetts, USA, in a randomized, placebo-controlled trial testing twice-daily SBD111 synbiotic for safety, tolerability, and gut microbiome effects over 28–56 days. machine-written summary
93 samples · 93 runs · US · Adult · 2022 · 5.39 Gbp / sample
Checked this project's papers and archive records yourself? Mark it human-verified.
what each source gave
| ✓ Sequence archive | 727 sample values (collection date, country, intervention, latitude, location region, longitude, subject id, timepoint) |
| ✓ Abstract / description | 93 sample values (health condition detail) |
| ✓ Full text | 279 sample values (antibiotic exposure, health condition, location locality) · PMC11649316 |
| – Supplementary tables | no supplementary tables available (or none open access) |
| – External resources | not covered by the external resources we ingest |
| – User contribution | nothing uploaded yet |
| – Human verified | not yet checked by a person · I checked this project — verify it |
intervention · arms resolved
Synbiotic (probiotic + prebiotic) design randomized_controlled_trial · population healthy_control · SBD111 synbiotic twice daily vs placebo, 28 days
“randomized, placebo-controlled trial over 28-days” — abstract:39687223 (study level; per-sample arms are in the intervention column below)
longitudinal — not resolved
Schedule stated by the source: “stool at baseline, 28 and 56 days” (time origin: intervention_start); stated follow-up 56 d.
Genera, mean relative abundance over 79 profiled gut samples of this project (Sandpiper SingleM profiles, GTDB R232; low-depth and non-metagenome profiles left out).
| field | samples | coverage | R1 | R2 | R3 | R4 |
|---|---|---|---|---|---|---|
| age_category | 93 | 100% | ||||
| country | 93 | 100% | 93 | |||
| health_condition | 93 | 100% | 93 | |||
| subject_id | 93 | 100% | 93 | |||
| antibiotic_exposure | 93 | 100% | 93 | |||
| collection_date | 93 | 100% | 93 | |||
| detailed_location | 93 | 100% | ||||
| health_condition_detail | 93 | 100% | 93 | |||
| latitude | 93 | 100% | 93 | |||
| location_locality | 93 | 100% | 93 | |||
| location_region | 93 | 100% | 93 | |||
| longitude | 93 | 100% | 93 | |||
| timepoint_label | 93 | 100% | 93 | |||
| intervention | 76 | 82% | 76 |
- Randomized clinical trial to test the safety and tolerability of SBD111, an optimized synbiotic medical food combination designed for the dietary management of the metabolic processes underlying osteopenia and osteoporosis. 2023 PMID 39687223 PMC11649316 own_data
Archive description
This study evaluates the effect of a daily administration (6.1 x 1010 CFU/d) of a synbiotic product on safety and tolerability in adults in a randomized trial. Based on the relatively low frequency and mild severity of GI symptoms and AEs, this study suggests that the synbiotic at the dose tested is safe for human consumption
How this project entered the registry
Classified as human gut / stool shotgun DNA metagenome of adult by sonnet_x2 with confidence 0.70. Assay shotgun_dna.
- host run.host_tax_id · “9606”
- body site run.scientific_name · “human gut metagenome”
- life stage study.description · “safety and tolerability in adults”
Evidence examples (one per field × route)
| sample | field | value | route | conf. | source | quote |
|---|---|---|---|---|---|---|
| SAMN26363642 | antibiotic_exposure | no | R3 | 0.70 | paper.fulltext.methods | not using probiotic or prebiotic supplements or antibiotic treatment |
| SAMN26363642 | collection_date | 2021-10-03 | R1 | 0.90 | biosample.attribute:collection_date | 2021-10-03 |
| SAMN26363642 | country | US | R1 | 0.90 | sample.attr.geo_loc_name | USA:Massachusetts |
| SAMN26363642 | health_condition | healthy_control | R3 | 0.70 | paper.fulltext.abstract | safety and tolerability in healthy adults |
| SAMN26363642 | health_condition_detail | healthy adults | R4 | 0.50 | paper.abstract | healthy adults in a randomized, placebo-controlled trial |
| SAMN26363642 | intervention | synbiotic | R1 | 0.85 | biosample.attribute:DESCRIPTION | DESCRIPTION: intervention group-DAY 28 |
| SAMN26363642 | latitude | 42.4000 | R1 | 0.90 | biosample.attribute:lat_lon | 42.40 N 71.38 W |
| SAMN26363642 | location_locality | Roslindale | R3 | 0.70 | paper.fulltext.methods | conducted in Roslindale, Massachusetts |
| SAMN26363642 | location_region | Massachusetts | R1 | 0.85 | biosample.attribute:geo_loc_name | USA:Massachusetts |
| SAMN26363642 | longitude | -71.3800 | R1 | 0.90 | biosample.attribute:lat_lon | 42.40 N 71.38 W |
| SAMN26363642 | subject_id | 29-SBD111-DAY 28 | R1 | 0.85 | sample.attr.host_subject_id | 29-SBD111-DAY 28 |
| SAMN26363642 | timepoint_label | DAY 28 | R1 | 0.70 | sample.name_rule:host_subject_id | 29-SBD111-DAY 28 |
Sequencing
93 runs over 93 samples · mean 5.43 Gbp per run (median 5.39 Gbp, total 504.81 Gbp; 93 runs with a base count) · layout PAIRED 93 · platform ILLUMINA 93 · models Illumina NovaSeq 6000 (93) · 85% of runs with a Sandpiper profile · first public 2022-08-22 – 2022-08-28
Authors (7)
Sahni S first · Schott EM · Carroll D · Soto-Giron MJ · Corbett S · Toledo GV · Kiel DP last
Downloads
PRJNA811803.csv.gz (3.7 KB) · parquet (75.4 KB) — all 93 samples, every field with route and confidence · PRJNA811803_determinations.csv.gz (8.9 KB) — 1,099 evidence rows