Probiotic trial microbiome in German preterm infants
948 fecal samples from preterm infants (28–32 weeks gestation) across 18 German neonatal units, from the PRIMAL randomized, double-blind, placebo-controlled trial testing probiotics (B. infantis, BB-12, La-5) for preventing MDRO+ colonization and shaping microbiome development. machine-written summary
948 samples · 1,712 runs · DE · Infant / toddler · 2024 · 8.41 Gbp / sample
Checked this project's papers and archive records yourself? Mark it human-verified.
what each source gave
| ✓ Sequence archive | 2,838 sample values (country, health condition, health condition detail) |
| ✓ Abstract / description | 1,894 sample values (collection date, preterm status) |
| ✓ Full text | 6 sample values (health condition, health condition detail) · PMC12549143 |
| ○ Supplementary tables | files read; no table could be matched to the samples |
| – 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 not resolved
Probiotic (live microorganisms; single strain or mixture) design randomized_controlled_trial · population preterm_nicu · 28-day multistrain probiotic (B. infantis, BB-12, La-5) in preterm infants
“28-day course of multistrain probiotics diluted in human milk or formula” — bioproject.description (study level; per-sample arms are in the intervention column below)
longitudinal — not resolvedsiblings — not resolved
Schedule stated by the source: “Stool samples collected on day 3 and day 30 of life (timing varied: day 3 median 3 [2-4] d; day 30 median 30 [28-31] d)” (time origin: birth).
Text notes one sibling pair among enrolled preterm infants; not identifiable per sample from archive fields.
Genera, mean relative abundance over 873 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 | 946 | 100% | ||||
| country | 948 | 100% | 948 | |||
| health_condition | 948 | 100% | 945 | 3 | ||
| subject_id | 0 | 0% | ||||
| collection_date | 948 | 100% | 948 | |||
| health_condition_detail | 948 | 100% | 945 | 3 | ||
| preterm_status | 946 | 100% | 946 |
- Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial. 2024 PMID 39102225 PMC12549143 own_data
Archive description
The PRiming IMmunity At the beginning of Life (PRIMAL) trial (German Clinical Trials Register: DRKS00013197) was a multicenter, double-blind, placebo-controlled, group sequential, phase 3 randomized clinical trial conducted from April 2018 to June 2020 across 18 German neonatal units. PRIMAL aimed to study the effects of probiotic interventions on colonization with multidrug-resistant organisms or highly epidemic bacteria (MDRO+) and early microbiome development in preterm infants born at gestational ages of 28 to 32 weeks. Specifically, the trial examined the efficacy of Bifidobacterium longum subsp. infantis, Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (La-5) probiotics in preventing MDRO+ colonization and in shaping the microbiome of preterm infants toward the eubiotic state observed in healthy full-term infants. The intervention consisted of a 28-day course of multistrain probiotics diluted in human milk or formula, initiated within the first 72 hours of life.
How this project entered the registry
Classified as human gut / stool / human milk shotgun DNA metagenome of infant / toddler and neonate by deterministic_prior with confidence 0.90. Assay shotgun_dna.
- host external_curation.infant_catalog · “infant triage verdict include”
- body site study.title · “PRIMAL fecal samples shotgun metagenome”
- body site external_curation.infant_catalog · “infant triage verdict include (gut/stool scope)”
- body site study.description · “probiotics diluted in human milk or formula, initiated”
- life stage external_curation.infant_catalog · “infant triage verdict include (0-3 y scope)”
- life stage study.description · “development in preterm infants born at gestational”
- life stage study.description · “across 18 German neonatal units. PRIMAL aimed”
Evidence examples (one per field × route)
| sample | field | value | route | conf. | source | quote |
|---|---|---|---|---|---|---|
| SAMEA115997523 | collection_date | 2018-04/2020-06 | R4 | 0.45 | ena.study_description | conducted from April 2018 to June 2020 |
| SAMEA115997523 | country | DE | R1 | 0.90 | biosample_attr | Germany |
| SAMEA115997523 | health_condition | preterm_nicu | R1 | 0.85 | biosample.attribute:environmental_medium | feces [ENVO:00002003] |
| SAMEA115997551 | health_condition | preterm_nicu | R3 | 0.70 | paper.body.methods_results | within the gestational age range of 28 weeks 0 days and 32 weeks 6 days |
| SAMEA115997523 | health_condition_detail | feces [ENVO:00002003] | R1 | 0.85 | biosample.attribute:environmental_medium | feces [ENVO:00002003] |
| SAMEA115997551 | health_condition_detail | preterm infants, gestational age 28w0d-32w6d | R3 | 0.70 | paper.body.methods_results | within the gestational age range of 28 weeks 0 days and 32 weeks 6 days |
| SAMEA115997523 | preterm_status | preterm | R4 | 0.50 | study.description | preterm infants born at gestational ages 28 to 32 weeks |
Sequencing
1,712 runs over 948 samples · mean 4.76 Gbp per run (median 4.78 Gbp, total 8,151.80 Gbp; 1,712 runs with a base count) · layout PAIRED 1,212, SINGLE 500 · platform ILLUMINA 1,712 · models Illumina HiSeq 4000 (944), Illumina NovaSeq 6000 (768) · 87% of runs with a Sandpiper profile · first public 2024-09-19
Authors (0)
No author record.
Downloads
PRJEB79896.csv.gz (24.6 KB) · parquet (109.4 KB) — all 948 samples, every field with route and confidence · PRJEB79896_determinations.csv.gz (23.8 KB) — 4,738 evidence rows