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Recruiting NCT03148743

FMT in Gut aGVHD Treated

Observational Acute-graft-versus-host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal microbiota.
Who it may be relevant to
Registry conditions: Acute-graft-versus-host Disease. Basic parameters: 10 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Department of Hematology of First Affiliated Hospital of Soochow University

Overview

With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.

Interventions

  • Biological Fecal microbiota
    fecal microbiota transplantation

Primary outcome measures

  • times of stool [Time frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week]
Secondary outcome measures (1)
  • volume in milliliter of stool [Time frame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week]

Eligibility criteria

Inclusion criteria

  • gut GVHD

Exclusion criteria

  • Age>60; or Age<10

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

China · 1 center
  • 中国 — Suzhou

Publications

  • Liu Y, Zhao Y, Qi J, Ma X, Qi X, Wu D, Xu Y. Fecal microbiota transplantation combined with ruxolitinib as a salvage treatment for intestinal steroid-refractory acute GVHD. Exp Hematol Oncol. 2022 Nov 9;11(1):96. doi: 10.1186/s40164-022-00350-6. PMID 36352455
  • Zhao Y, Li X, Zhou Y, Gao J, Jiao Y, Zhu B, Wu D, Qi X. Safety and Efficacy of Fecal Microbiota Transplantation for Grade IV Steroid Refractory GI-GvHD Patients: Interim Results From FMT2017002 Trial. Front Immunol. 2021 Jun 17;12:678476. doi: 10.3389/fimmu.2021.678476. eCollection 2021. PMID 34220825
  • Qi X, Li X, Zhao Y, Wu X, Chen F, Ma X, Zhang F, Wu D. Treating Steroid Refractory Intestinal Acute Graft-vs.-Host Disease With Fecal Microbiota Transplantation: A Pilot Study. Front Immunol. 2018 Sep 25;9:2195. doi: 10.3389/fimmu.2018.02195. eCollection 2018. PMID 30319644

Identifiers

NCT: NCT03148743 · FMT2017002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗