Evidence map›Paper›PMID 35193638›Full record

ArticleTrials2022

Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial.

Andreas Stallmach, Philip Grunert, Johannes Stallhofer, Bettina Löffler, Michael Baier, Jürgen Rödel, Michael Kiehntopf, Sophie Neugebauer, Dietmar H Pieper, Howard Junca and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03843385 (Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

NCT03843385 phase3active not recruitingnot on this mapstarted 2023, after this paper: background citation

Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis

TypeinterventionalSponsorAndreas StallmachRan2023 to 2027Enrolled84ConditionsUlcerative Colitis, Inflammatory Bowel DiseasesArmsencapsulated faecal microbiota filtrate, encapsulated faecal microbiota, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Current perspectives on fecal microbiota transplantation in inflammatory bowel disease.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Review
  7. Review
  8. Article
  9. Review
  10. Fecal transplantation for treatment of inflammatory bowel disease.The Cochrane database of systematic reviews · 2023
    Review
  11. Fecal microbiota transfer to treat ulcerative colitis: Medical and legal challenges.Frontiers in gastroenterology (Lausanne, Switzerland) · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 4 institutions in 1 country.

Andreas StallmachDepartment of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University of Jena, Am Klinikum 1, 07747, Jena, Germany. andreas.stallmach@med.uni-jena.de.
Philip GrunertDepartment of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University of Jena, Am Klinikum 1, 07747, Jena, Germany.
Johannes StallhoferDepartment of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University of Jena, Am Klinikum 1, 07747, Jena, Germany.
Bettina LöfflerInstitute of Medical Microbiology, Jena University Hospital, Friedrich Schiller University, Jena, Germany.
Michael BaierInstitute of Medical Microbiology, Jena University Hospital, Friedrich Schiller University, Jena, Germany.
Jürgen RödelInstitute of Medical Microbiology, Jena University Hospital, Friedrich Schiller University, Jena, Germany.
Michael KiehntopfInstitute for Clinical Chemistry and Laboratory Diagnostics and Integrated Biobank Jena, Jena University Hospital, Jena, Germany.
Sophie NeugebauerInstitute for Clinical Chemistry and Laboratory Diagnostics and Integrated Biobank Jena, Jena University Hospital, Jena, Germany.
Dietmar H PieperMicrobial Interactions and Processes Research Group, Helmholtz Centre for Infection, Braunschweig, Germany.
Howard JuncaMicrobial Interactions and Processes Research Group, Helmholtz Centre for Infection, Braunschweig, Germany.
Andrea TannapfelInstitute for Pathology, Ruhr University, Bochum, Germany.
Ute MerkelHospital Pharmacy, Jena University Hospital, Jena, Germany.
Ulrike SchumacherCenter for Clinical Studies Jena (ZKS), Jena University Hospital, Jena, Germany.
Maria Breternitz-GruhneCenter for Clinical Studies Jena (ZKS), Jena University Hospital, Jena, Germany.
Tabitha HellerCenter for Clinical Studies Jena (ZKS), Jena University Hospital, Jena, Germany.
Anja SchauerDepartment of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University of Jena, Am Klinikum 1, 07747, Jena, Germany.
Michael HartmannHospital Pharmacy, Jena University Hospital, Jena, Germany.
Arndt SteubeDepartment of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University of Jena, Am Klinikum 1, 07747, Jena, Germany.
Jena University Hospital · DEFriedrich Schiller University Jena · DEHelmholtz Centre for Infection Research · DERuhr University Bochum · DE

Funding

Bundesministerium für Bildung und Forschung 01KG1814
6 · The paper itself

Abstract

backgroundUlcerative colitis (UC) is a chronic inflammatory bowel disease with significant morbidity and mortality. Although the precise cause remains unknown, disturbances in the intestinal microbial community have been linked to its pathogenesis. Randomized controlled trials in UC and relapsing Clostridioides difficile infection (CDI) have established fecal microbiota (FM) transfer (FMT) as an effective therapy. In this context, preliminary results indicated that the transfer of sterile fecal microbiota filtrates (<0.2 μm; FMF, FMFT) of donor stool also drives gastrointestinal microbiota changes and eliminates symptoms in CDI patients. However, along with the success of FMT, regulatory agencies issued safety alerts following reports of serious adverse events due to transmission of enteric pathogens through FMT. To reduce this risk, we established an extensive test protocol for our donors and quarantine regulations for the produced capsules, but alternative concepts are desirable.

methodsOur project is a randomized, controlled, longitudinal, prospective, three-arm, multicenter, double-blind study to determine the safety and efficacy of repeated long-term, multi-donor FM or FMF transfers compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active UC. The primary outcome will be clinical remission at week 12. DISCUSSION: This proposal aims to examine (a) the efficacy of encapsulated transfer of FM and FMF as a therapy for mild to moderate UC, (b) the short- and long-term safety of FMT and FMFT in patients with UC, and (c) the microbial and immunologic changes that occur after FMT and FMFT to help understand how and why it affects inflammatory bowel disease.

trial registrationClinicalTrials.gov NCT03843385 . DRKS (Deutsches Register für Klinische Studien) DRKS00020471.

Indexed as

Colitis, UlcerativeDouble-Blind MethodFecal Microbiota TransplantationFecesHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicTreatment OutcomeFecal microbiota transferFecal microbiota transplantationRandomized controlled trialUlcerative colitis

Identifiers

PMID35193638
PMCPMC8861997
OpenAlexW4212910851

What OpenQuestion holds

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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 OpenQuestion graph.