Evidence map›Paper›PMID 30972640›Full record

ArticleDrug safety2019

Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis.

Xiao Ding, Qianqian Li, Pan Li, Ting Zhang, Bota Cui, Guozhong Ji, Xiang Lu, Faming Zhang

3 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 88 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 4 pooled it
13.7field-weighted citation impact, top 1% 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.

NCT01790061 phase2 / phase3unknown statusnot on this map

Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2013 to 2025Enrolled500ConditionsBacteria, Microbiota, Fecal Microbiota Transplantation, Inflammatory Bowel DiseaseArmsStandardized FMT, Traditional treatments
NCT02560727 unknown statusnot on this map

Feasibility, Safety, and Efficacy of Transendoscopic Enteral Tubing in Fecal Microbiota Transplantation

TypeobservationalSponsorThe Second Hospital of Nanjing Medical UniversityRan2014 to 2016Enrolled200ConditionsInflammatory Bowel DiseasesArmstransendoscopic enteral tubing, colonoscope
NCT04251767 nawithdrawnnot on this mapstarted 2020, after this paper: background citation

Washed Microbiota Transplantation for Patients With 2019-nCoV Infection: a Randomized, Double-blind, Placebo-controlled Study

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2020 to 2020Enrolled0ConditionsCOVID-19 Complicated With Refractory Intestinal InfectionsArmswashed microbiota transplantation, placebo
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 4 syntheses or guidelines pooled it, 139 citations in OpenAlex.

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28 more citing papers are in PubMed but not listed here.

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.

Xiao DingMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Qianqian LiMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Pan LiMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Ting ZhangMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Bota CuiMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Guozhong JiMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China.
Xiang LuDepartment of Geriatrics, Sir Run Run Hospital, Nanjing Medical University, 109 Longmian Ave, Nanjing, 211166, China. luxiang66@njmu.edu.cn.
Faming ZhangMedical Center for Digestive Diseases, The Second Affiliated Hospital, Nanjing Medical University, 121 Jiang Jia Yuan, Nanjing, 210011, China. fzhang@njmu.edu.cn.ORCID 0000-0003-4157-1144
Second Affiliated Hospital of Nanjing Medical University · CNNanjing Medical University · CNNanjing University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION AND

objectiveThe therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis.

methodsTwo clinical trials (NCT01790061, NCT02560727) for moderate-to-severe ulcerative colitis (Mayo score range 6-12) were performed from November 2012 to July 2017. Both studies were pooled for analysis on the safety and efficacy of fecal microbiota transplantation in patients with ulcerative colitis over a 1-year follow-up. The step-up fecal microbiota transplantation strategy included step 1: single fecal microbiota transplantation; step 2: two or more fecal microbiota transplantations; and step 3: fecal microbiota transplantations followed by immunosuppressants. Long-term clinical efficacy and adverse events were assessed, and multiple factors related to fecal microbiota transplantation were evaluated.

resultsOf 134 eligible patients in this real-word study, 81.3% (109/134) were included for analysis. The follow-up ranged from 1 to 5 years. Fecal microbiota transplantation-related adverse events were observed in 17.4% (43/247) of fecal microbiota transplantation procedures including one serious adverse event (myasthenia gravis) and 56 non-serious adverse events. Multivariable logistic regression analysis showed that both the method of preparation of microbiota from stool using the automatic system and the delivery method of colonic transendoscopic enteral tubing were associated with a lower rate of fecal microbiota transplantation-related adverse events (p = 0.023, p = 0.017, respectively). In total, 74.3% (81/109) and 51.4% (56/109) of patients achieved clinical response at 1 month and 3 months after step-up fecal microbiota transplantation, respectively.

conclusionsFecal microbiota transplantation should be a safe and promising therapy for ulcerative colitis. The improved fecal microbiota preparation and colonic transendoscopic enteral tubing might reduce the rate of adverse events in ulcerative colitis.

trial registrationClinicalTrials.gov NCT01790061, NCT02560727.

Indexed as

Fecal Microbiota TransplantationGastrointestinal MicrobiomeAdolescentAdultAgedChildColitis, UlcerativeFecesFemaleHumansMaleMiddle AgedYoung Adult

Identifiers

PMID30972640
OpenAlexW2938920814

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.