Evidence map›Paper›PMID 38296309›Full record

Trial reportRMD open2024

Dynamics of inflammation-associated plasma proteins following faecal microbiota transplantation in patients with psoriatic arthritis and healthy controls: exploratory findings from the FLORA trial.

Maja Skov Kragsnaes, Jennifer Rugaard Bregndahl Jensen, Anna Christine Nilsson, Muhammad Irfan Malik, Heidi Lausten Munk, Jens Kristian Pedersen, Hans Christian Horn, Mogens Kruhøffer, Karsten Kristiansen, Benjamin H Mullish and 4 more

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03058900 (Efficacy and Safety of Fecal Microbiota Transplantation), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
5.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03058900 nacompletednot on this map

Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Peripheral Psoriatic Arthritis: a 6-month, Double-Blind, Randomized, Placebo-Controlled Trial

TypeinterventionalSponsorOdense University HospitalRan2017 to 2020Enrolled31ConditionsPsoriatic ArthritisArmsFecal microbiota transplantation (FMT), Drug: Placebo (saline), Methotrexate (MTX)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. Psoriatic Arthritis: Developments in 2025.Mediterranean journal of rheumatology · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Gut microbiota and psoriasis: pathogenesis, targeted therapy, and future directions.Frontiers in cellular and infection microbiology · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 6 countries.

Maja Skov Kragsnaes *Department of Rheumatology, Odense University Hospital, Odense, Denmark maja.kragsnaes@dadlnet.dk.ORCID 0000-0001-9641-9065
Jennifer Rugaard Bregndahl Jensen *Department of Mathematics and Computer Science (IMADA), University of Southern Denmark, Odense, Denmark.
Anna Christine NilssonDepartment of Clinical Immunology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-7885-8400
Muhammad Irfan MalikDepartment of Mathematics and Computer Science (IMADA), University of Southern Denmark, Odense, Denmark.
Heidi Lausten MunkDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.
Jens Kristian PedersenDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.
Hans Christian HornDepartment of Rheumatology, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-0792-0366
Mogens KruhøfferBioXpedia A/S, Aarhus, Denmark.
Karsten KristiansenDepartment of Biology, Laboratory of Genomics and Molecular Biomedicine, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6024-0917
Benjamin H MullishDivision of Digestive Diseases, Imperial College London Faculty of Medicine, London, UK.ORCID 0000-0001-6300-3100
Julian R MarchesiDivision of Digestive Diseases, Imperial College London Faculty of Medicine, London, UK.ORCID 0000-0002-7994-5239
Jens KjeldsenDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.ORCID 0000-0001-8148-6572
Richard RöttgerDepartment of Mathematics and Computer Science (IMADA), University of Southern Denmark, Odense, Denmark.
Torkell EllingsenDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark.ORCID 0000-0003-0426-4962
University of Southern Denmark · DKOdense University Hospital · DKCentre For Digestive Diseases · AUImperial College Healthcare NHS Trust · GBUniversity of Copenhagen · DK

Funding

NIHR Academic Clinical Lectureship CL-2019-21-002Sygeforsikringen 'danmark' 2022-0026
6 · The paper itself

Abstract

objectivesThe gut microbiota can mediate both pro and anti-inflammatory responses. In patients with psoriatic arthritis (PsA), we investigated the impact of faecal microbiota transplantation (FMT), relative to sham transplantation, on 92 inflammation-associated plasma proteins.

methodsThis study relates to the FLORA trial cohort, where 31 patients with moderate-to-high peripheral PsA disease activity, despite at least 3 months of methotrexate treatment, were included in a 26-week, double-blind, randomised, sham-controlled trial. Participants were allocated to receive either one gastroscopic-guided healthy donor FMT (n=15) or sham (n=16). Patient plasma samples were collected at baseline, week 4, 12 and 26 while samples from 31 age-matched and sex-matched healthy controls (HC) were collected at baseline. Samples were analysed using proximity extension assay technology (Olink Target-96 Inflammation panel).

resultsLevels of 26 proteins differed significantly between PsA and HC pre-FMT (adjusted p<0.05), of which 10 proteins were elevated in PsA: IL-6, CCL20, CCL19, CDCP1, FGF-21, HGF, interferon-γ (IFN-γ), IL-18R1, monocyte chemotactic protein 3, and IL-2. In the FMT group, levels of 12 proteins changed significantly across all timepoints (tumour necrosis factor (TNF), CDCP1, IFN-γ, TWEAK, signalling lymphocytic activation molecule (SLAMF1), CD8A, CD5, Flt3L, CCL25, FGF-23, CD6, caspase-8). Significant differences in protein levels between FMT and sham-treated patients were observed for TNF (p=0.002), IFN-γ (p=0.011), stem cell factor (p=0.024), matrix metalloproteinase-1 (p=0.038), and SLAMF1 (p=0.042). FMT had the largest positive effect on IFN-γ, Axin-1 and CCL25 and the largest negative effect on CCL19 and IL-6.

conclusionsPatients with active PsA have a distinct immunological plasma protein signature compared with HC pre-FMT. FMT affects several of these disease markers, including sustained elevation of IFN-γ. TRIAL REGISTRATION NUMBER: NCT03058900.

Indexed as

Arthritis, PsoriaticAntigens, NeoplasmCell Adhesion MoleculesFecal Microbiota TransplantationHumansInflammationInterleukin-6Treatment OutcomeTumor Necrosis Factor-alphaAntigens, NeoplasmCDCP1 protein, humanCell Adhesion MoleculesInterleukin-6Tumor Necrosis Factor-alphaArthritis, PsoriaticCytokinesInflammation

Identifiers

PMID38296309
PMCPMC10836383
OpenAlexW4391398845

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.