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PRJNA643353 SRP270378

Gut microbiome in T2D adults, BBR/probiotic RCT, China

The gut microbiome related effect of Berberine and probiotics in treating Type 2 Diabetes

1191 gut metagenome samples from adults with type 2 diabetes in Shanghai, China, from a randomized, double-blind, placebo-controlled trial testing berberine and/or probiotics alongside antibiotic pretreatment. machine-written summary

1,192 samples · 1,192 runs · CN · Adult · 2021 · 10.73 Gbp / sample

Sources
✓Sequence archive 10,786○Abstract / description✓Full text 2✓Supplementary tables 3,022–External resources–User contribution–Human verified

Checked this project's papers and archive records yourself? Mark it human-verified.

what each source gave
✓ Sequence archive10,786 sample values (antibiotic exposure, collection date, country, health condition, health condition detail, intervention, latitude, location region)
○ Abstract / descriptionread; no usable statement
✓ Full text2 sample values (health condition, health condition detail) · PMC11170963, PMC11438002, PMC7538905, PMC8318886, PMC8726654
✓ Supplementary tables3,022 sample values (age, bmi, intervention, sex, subject id, timepoint)
– External resourcesnot covered by the external resources we ingest
– User contributionnothing uploaded yet
– Human verifiednot yet checked by a person · I checked this project — verify it
Interventions

intervention · arms resolved

RAntibiotic given as the study intervention (incl. eradication therapy: 403 people · 403 samplesantibiotic 403 people · 403 samplesOther administered intervention (see intervention_detail): 104 people · 104 samplesother 104 people · 104 samplesProbiotic (live microorganisms; single strain or mixture): 98 people · 98 samplesprobiotic 98 people · 98 samplesNon-antibiotic pharmaceutical given as the study intervention (metformin: 85 people · 85 samplesdrug 85 people · 85 samplesControl / pre-intervention baseline (sample level only): 405 people · 405 samplesno intervention 405 people · 405 samplesPlacebo / sham arm (sample level only): 97 people · 97 samplesplacebo 97 people · 97 samples
randomised to parallel arms

405 people have samples in more than one arm.

Antibiotic given as the study intervention (incl. eradication therapy Non-antibiotic pharmaceutical given as the study intervention (metformin Probiotic (live microorganisms; single strain or mixture) design randomized_controlled_trial · population type2_diabetes · Berberine and/or probiotics vs placebo, with gentamycin run-in pretreatment

“receive BBR, probiotic with BBR, probiotics, or placebo” — bioproject.description (study level; per-sample arms are in the intervention column below)

Samples at a glance
1 sampling locations · 1 country
Age
adult1,156
elderly36
Condition
type2_diabetes1,192
Sex
male216
female146
Country
CN1,192
Body site
unknown1,192
Sequencing depth per sample · this project all projects
all projects, 0–0.03 Gbp: 25,080 samples (4 %)all projects, 0.03–0.1 Gbp: 17,066 samples (3 %)all projects, 0.1–0.3 Gbp: 29,179 samples (5 %)all projects, 0.3–1 Gbp: 47,044 samples (8 %)all projects, 1–3 Gbp: 124,983 samples (22 %)all projects, 3–10 Gbp: 253,728 samples (44 %)this project, 3–10 Gbp: 515 samplesall projects, 10–30 Gbp: 72,533 samples (13 %)this project, 10–30 Gbp: 677 samplesall projects, 30–100 Gbp: 3,024 samples (1 %)all projects, 100–300 Gbp: 106 samples (0 %)all projects, ≥ 300 Gbp: 9 samples (0 %)project median 10.73 Gbp per sample0130Gbp
Sampling design and relatedness

longitudinal

405 of 409 people sampled more than once (1,188 samples; median 3, up to 3 per person) · follow-up median 3 mo (max 3 mo) · median interval between samples 3 mo (time from timepoint labels). Schedule stated by the source: “stool after 1-week gentamycin run-in, at baseline (treatment start), and post-treatment at week 13 (end of 12-week intervention)”.

R1215R1215: day 0R1215: day 840 d21 d42 d2 mo3 mo

Each row is one person (1 shown of 405); dots are samples at days since that person's first sample.

How longitudinal and relatedness information is derived

Community composition

No Sandpiper profile for this project's samples yet.

Field coverage
fieldsamplescoverageR1R2R3R4
age_category1,192 100%
country1,192 100%1,192
health_condition1,192 100%1,1911
subject_id1,192 100%830362
health_condition_detail1,192 100%1,1911
intervention1,192 100%808384
timepoint_label1,192 100%21,190
collection_date1,191 100%1,191
detailed_location1,191 100%
latitude1,191 100%1,191
location_region1,191 100%1,191
longitude1,191 100%1,191
antibiotic_exposure808 68%808
age_at_collection_days362 30%362
bmi362 30%362
sex362 30%362
Papers (5)
  • Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). 2020 PMID 33024120 PMC7538905 own_data
  • Combined berberine and probiotic treatment as an effective regimen for improving postprandial hyperlipidemia in type 2 diabetes patients: a double blinded placebo controlled randomized study. 2022 PMID 34923903 PMC8726654 own_data
  • Probiotics impact the antibiotic resistance gene reservoir along the human GI tract in a person-specific and antibiotic-dependent manner. 2021 PMID 34226711 PMC8318886 unsure
  • Deciphering unique and shared interactions between the human gut microbiota and oral antidiabetic drugs. 2024 PMID 38882498 PMC11170963 unsure
  • Clinical significance of the genetically variable landscape of the gut microbiome in patients with gestational diabetes mellitus patients. 2024 PMID 39347390 PMC11438002 unsure
Details
Archive description

We conducted a randomized, double-blind, placebo-controlled trial on newly diagnosed type 2 diabetes (T2D) patients from 20 centers in China. Eligible participants (n= 409) were randomly assigned (1:1:1:1) to receive BBR, probiotic with BBR, probiotics, or placebo for 3 months. Compared to the placebo, BBR effectively decreased the glycated hemoglobin (HbA1c) and blood lipids with its substantial impact on the gut microbiome.

How this project entered the registry

Classified as human gut / stool / blood / tissue / internal fluids shotgun DNA metagenome of adult by deterministic_prior with confidence 0.90. Assay shotgun_dna.

  • host external_curation.infant_catalog · “infant triage reason_code age_adult_only”
  • body site study.title · “The gut microbiome related effect”
  • body site study.description · “impact on the gut microbiome.”
  • body site study.description · “hemoglobin (HbA1c) and blood lipids with its”
  • life stage external_curation.infant_catalog · “infant triage reason_code age_adult_only”
Evidence examples (one per field × route)
samplefieldvaluerouteconf.sourcequote
SAMN15421765age_at_collection_days21549.75R20.85paper.supp.IMT2-3-e179-s001.xlsx[ Table S2!Age (Years)]59
SAMN15421765antibiotic_exposurenoR10.85sample.name_rule:isolation_sourceR0101_base
SAMN15421765bmi26.54R20.85paper.supp.IMT2-3-e179-s001.xlsx[ Table S2!BMI (kg/m^2)]26.54
SAMN15421765collection_date2017R10.90biosample.attribute:collection_date2017
SAMN15421765countryCNR10.90sample.attr.geo_loc_nameChina:Shanghai
SAMN15421765health_conditiontype2_diabetesR10.85sample.name_rule:isolation_sourceR0101_base
SAMN15422692health_conditiontype2_diabetesR30.70paper.fulltext.methodsnewly diagnosed T2D according to the World Health Organization criteria
SAMN15421765health_condition_detailbaseR10.85sample.name_rule:isolation_sourceR0101_base
SAMN15422692health_condition_detailnewly diagnosed T2D according to the World Health Organization criteriaR30.70paper.fulltext.methodsnewly diagnosed T2D according to the World Health Organization criteria
SAMN15421765interventionno_interventionR10.85sample.name_rule:isolation_sourceR0101_base
SAMN15421767interventiondrug_therapyR20.85paper.supp.IMT2-3-e179-s001.xlsx[ Table S2!Intervention]Berberine
SAMN15421765latitude31.2300R10.90biosample.attribute:lat_lon31.23 N 121.47 E
SAMN15421765location_regionShanghaiR10.85biosample.attribute:geo_loc_nameChina:Shanghai
SAMN15421765longitude121.4700R10.90biosample.attribute:lat_lon31.23 N 121.47 E
SAMN15421765sexmaleR20.85paper.supp.IMT2-3-e179-s001.xlsx[ Table S2!Sex]male
SAMN15421766subject_idR0101R10.70sample.name_rule:aliasR0101V2
SAMN15422692subject_idR1417R10.70sample.name_rule:library_namelibrary_name: R1417V5; isolation_source R1417_treat
SAMN15421765subject_idR0101R20.85paper.supp.IMT2-3-e179-s001.xlsx[ Table S2!Patient ID]R0101
SAMN15421766timepoint_labelV2R10.70sample.name_rule:aliasR0101V2
SAMN15422692timepoint_labelV5R10.70sample.name_rule:library_namelibrary_name: R1417V5
SAMN15421765timepoint_labelD0R20.85paper.supp.IMT2-3-e179-s001.xlsx[ Table S2!Time]D0
Sequencing

1,192 runs over 1,192 samples · mean 11.22 Gbp per run (median 10.73 Gbp, total 13,369.46 Gbp; 1,192 runs with a base count) · layout PAIRED 1,192 · platform BGISEQ 1,192 · models BGISEQ-500 (1,192) · 0% of runs with a Sandpiper profile · first public 2021-09-01

Authors (61)

Zhang Y first · Gu Y · Ren H · Wang S · Zhong H · Zhao X · Ma J · Gu X · Xue Y · Huang S · Yang J · Chen L · Chen G · Qu S · Liang J · Qin L · Huang Q · Peng Y · Li Q · Wang X · Kong P · Hou G · Gao M · Shi Z · Li X · Qiu Y · Zou Y · Yang H · Wang J · Xu G · Lai S · Li J · Ning G · Wang W last · Montassier E first · Valdés-Mas R · Batard E · Zmora N · Dori-Bachash M · Suez J · Elinav E last · Li C · Li T · Yang F · Yuan F · Li M · Zhu J · Wu K · Kristiansen K · Zhang K first · Hu M · Yang W · Hu Z · Rong Y · Luo B · Wang M · Cheng Y · Zhang R · Lv N · Zhou Q · Zhang X last

Downloads

PRJNA643353.csv.gz (34.7 KB) · parquet (119.0 KB) — all 1,192 samples, every field with route and confidence · PRJNA643353_determinations.csv.gz (118.4 KB) — 13,810 evidence rows

Samples (1,192 · every field this project has values for · hover a cell for its source)
Loading the sample table…