Evidence map›Paper›PMID 34220825›Full record

Trial reportFrontiers in immunology2021

Safety and Efficacy of Fecal Microbiota Transplantation for Grade IV Steroid Refractory GI-GvHD Patients: Interim Results From FMT2017002 Trial.

Ye Zhao, Xuewei Li, Yujing Zhou, Jin Gao, Yang Jiao, Baoli Zhu, Depei Wu, Xiaofei Qi

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Frontiers in immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03148743 (Department of Hematology of First Affiliated Hospital of Soochow University), which is not on this map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 5% 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.

NCT03148743 recruitingnot on this map

Department of Hematology of First Affiliated Hospital of Soochow University

TypeobservationalSponsorThe First Affiliated Hospital of Soochow UniversityRan2017 to 2029Enrolled50ConditionsAcute-graft-versus-host DiseaseArmsFecal microbiota
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  5. Potential of Fecal Microbiota Transplantation to Prevent Acute GVHD: Analysis from a Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. CommensalGut · 2025
    Article
  13. Gut microbiota shapes cancer immunotherapy responses.NPJ biofilms and microbiomes · 2025
    Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

8 authors at 3 institutions in 1 country.

Ye ZhaoDepartment of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Xuewei LiDepartment of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Yujing ZhouCenter for Clinical Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.
Jin GaoState Key Laboratory of Radiation Medicine and Protection, School of Radiation Medicine and Protection, Soochow University, Suzhou, China.
Yang JiaoState Key Laboratory of Radiation Medicine and Protection, School of Radiation Medicine and Protection, Soochow University, Suzhou, China.
Baoli ZhuChinese Academy of Sciences (CAS) Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing, China.
Depei WuDepartment of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Xiaofei QiDepartment of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Soochow University · CNFirst Affiliated Hospital of Soochow University · CNInstitute of Microbiology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Gastrointestinal (GI) tract graft-versus-host disease (GvHD) is a major cause of post-allo-HSCT (hematopoietic stem cell transplantation) morbidity and mortality. Patients with steroid-refractory GI-GvHD have a poor prognosis and limited therapeutic options. FMT2017002 trial (#NCT03148743) was a non-randomized, open-label, phase I/II clinical study of FMT for treating patients with grade IV steroid-refractory GI-GvHD. A total of 55 patients with steroid-refractory GI-GvHD were enrolled in this study. Forty-one patients with grade IV steroid-refractory GI-GvHD were included in the final statistical analysis. Of them, 23 patients and 18 patients were assigned to the FMT group and the control group, respectively. On days 14 and 21 after FMT, clinical remission was significantly greater in the FMT group than in the control group. Within a follow-up period of 90 days, the FMT group showed a better overall survival (OS). At the end of the study, the median survival time was >539 days in the FMT group and 107 days in the control group (HR=3.51; 95% CI, 1.21-10.17; Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT03148743].

Indexed as

Fecal Microbiota TransplantationAdolescentAdultClinical Decision-MakingDisease ManagementDisease SusceptibilityDrug ResistanceFemaleGastrointestinal DiseasesGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansImmunosuppressive AgentsMaleMiddle AgedPrognosisImmunosuppressive AgentsSteroidsclinical trialsdiarrheafecal microbiota transplantationsgraft-versus-host diseaserefractory gastrointestinal

Identifiers

PMID34220825
PMCPMC8248496
OpenAlexW3176439830

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.