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PRJEB61882 ERP146964

FMT in advanced cirrhosis: RCT feasibility trial, UK

PROFIT Trial: FMT in cirrhosis

278 gut metagenome samples from adult cirrhosis patients in the United Kingdom, from a placebo-controlled randomised feasibility trial of jejunal faecal microbiota transplant (FMT). machine-written summary

278 samples · 278 runs · GB · Adult · 2024 · 13.27 Gbp / sample

Sources
✓Sequence archive 556✓Abstract / description 556–Full text–Supplementary tables–External resources–User contribution–Human verified

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

what each source gave
✓ Sequence archive556 sample values (collection date, country)
✓ Abstract / description556 sample values (health condition, health condition detail)
– Full textno open-access full text linked
– Supplementary tablesno supplementary tables available (or none open access)
– 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 not resolved

Faecal microbiota transplantation design randomized_controlled_trial · population liver_disease · FMT delivered via jejunum vs placebo in advanced cirrhosis patients

“placebo-controlled randomised-controlled feasibility trial of FMT transplanted into the jejunum” — bioproject.description (study level; per-sample arms are in the intervention column below)

Samples at a glance
1 country
Age
adult278
Condition
liver_disease278
Country
GB278
Body site
unknown278
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: 95 samplesall projects, 10–30 Gbp: 72,533 samples (13 %)this project, 10–30 Gbp: 180 samplesall projects, 30–100 Gbp: 3,024 samples (1 %)this project, 30–100 Gbp: 3 samplesall projects, 100–300 Gbp: 106 samples (0 %)all projects, ≥ 300 Gbp: 9 samples (0 %)project median 13.27 Gbp per sample0130Gbp
Sampling design and relatedness

FMT donor → recipient — not resolved

FMT vs placebo in cirrhosis; donor engraftment assessed by metagenomics; donor/recipient samples not distinguishable in archive metadata.

How longitudinal and relatedness information is derived

Community composition
Streptococcus 12.9%Bifidobacterium 11.5%Prevotella 5.8%Rothia 5.5%Pauljensenia 5.4%Actinomyces 5.1%Veillonella 3.5%Faecalibacterium 3.2%Neisseria 2.9%Blautia_A 1.9%Collinsella 1.7%Roseburia 1.6%not assigned to a genus 5.4%other genera 33.6%

Genera, mean relative abundance over 250 profiled gut samples of this project (Sandpiper SingleM profiles, GTDB R232; low-depth and non-metagenome profiles left out).

Field coverage
fieldsamplescoverageR1R2R3R4
age_category278 100%
country278 100%278
health_condition278 100%278
subject_id0 0%
collection_date278 100%278
health_condition_detail278 100%278
Papers (1)
  • Faecal microbiota transplant restores intestinal barrier function and augments ammonia metabolism in patients with cirrhosis: a randomised single-blind placebo-controlled trial 2023 own_data
Details
Archive description

Patients with liver cirrhosis have reduced gut bacterial diversity over-represented by pathobionts. This, coupled with increased gut permeability and bacterial translocation, increases susceptibility to infection and death. Faecal microbiota transplant [FMT] previously restored gut diversity and improved hepatic encephalopathy (HE) in 10 patients with cirrhosis. We performed a placebo-controlled randomised-controlled feasibility trial of FMT transplanted into the jejunum in 32 patients with advanced cirrhosis. The primary endpoint assessed safety, feasibility and tolerability of FMT. Secondary endpoints provided preliminary evidence of efficacy and mechanism. FMT was safe and well-tolerated with no serious adverse events. Deep metagenomic sequencing confirmed FMT increased recipient species richness with significant donor engraftment. FMT reduced intestinal barrier damage and systemic inflammation. FMT reduced microbial-associated ammonia production and augmented ammonia excretion via anaerobic metabolism of L-aspartate to hippurate providing proof of concept that FMT augments ammonia metabolism, central in the pathogenesis of HE, a debilitating complication of cirrhosis

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.description · “cirrhosis have reduced gut bacterial diversity over-represented”
  • body site external_curation.infant_catalog · “body_site_call gut”
  • body site study.description · “Patients with liver cirrhosis have reduced”
  • life stage external_curation.infant_catalog · “infant triage reason_code age_adult_only”
Evidence examples (one per field × route)
samplefieldvaluerouteconf.sourcequote
SAMEA113767010collection_date2019R10.90biosample.attribute:collection_date2019
SAMEA113767010countryGBR10.90sample.attr.geographic_location_country_and_or_seaUnited Kingdom
SAMEA113767010health_conditionliver_diseaseR40.50study.description32 patients with advanced cirrhosis
SAMEA113767010health_condition_detailAll patients have advanced liver cirrhosisR40.50study.description32 patients with advanced cirrhosis
Sequencing

278 runs over 278 samples · mean 14.06 Gbp per run (median 13.27 Gbp, total 3,907.85 Gbp; 278 runs with a base count) · layout PAIRED 278 · platform ILLUMINA 278 · models Illumina NovaSeq 6000 (278) · 90% of runs with a Sandpiper profile · first public 2024-09-16

Authors (24)

Shawcross D first · Edwards L · Woodhouse C · Lee S · Mullish B · Learoyd A · Portlock T · Flach C · Douiri A · Zamalloa A · Meoli L · Kronsten V · Yang X · Lynham S · Merrick B · Ribière C · Lelouvier B · Holmes S · Takis P · Marchesi J · Tranah T · Patel V · Shoaie S · Goldenberg S last

Downloads

PRJEB61882.csv.gz (7.0 KB) · parquet (78.8 KB) — all 278 samples, every field with route and confidence · PRJEB61882_determinations.csv.gz (5.6 KB) — 1,112 evidence rows

Samples (278 · every field this project has values for · hover a cell for its source)
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