Evidence map›Paper›PMID 30328062›Full record

Trial reportAdvances in therapy2018

The Safety of Fecal Microbiota Transplantation for Crohn's Disease: Findings from A Long-Term Study.

Honggang Wang, Bota Cui, Qianqian Li, Xiao Ding, Pan Li, Ting Zhang, Xiaozhong Yang, Guozhong Ji, Faming Zhang

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in Advances in therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 4 pooled it
6.9field-weighted citation impact, top 2% 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.

NCT01793831 narecruitingnot on this map

Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2013 to 2025Enrolled800ConditionsInflammatory Bowel Disease, Crohn&#39, s Disease (CD)ArmsFMT
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

51 citing papers in PubMed, 4 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
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  15. Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024
    Review
  16. Review
  17. The Next Generation Fecal Microbiota Transplantation: To Transplant Bacteria or Virome.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
    Review
  18. Review
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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

9 authors at 3 institutions in 1 country.

Honggang WangMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Bota CuiMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Qianqian LiMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiao DingMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Pan LiMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Ting ZhangMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Xiaozhong YangDepartment of Gastroenterology, The Affiliated Huaian No. 1 People's Hospital of Nanjing Medical University, Huai'an, China.
Guozhong JiMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. jgz@njmu.edu.cn.
Faming ZhangMedical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. fzhang@njmu.edu.cn.ORCID 0000-0003-4157-1144
Second Affiliated Hospital of Nanjing Medical University · CNNanjing University of Chinese Medicine · CNXuzhou Medical College · CN

Funding

China National Science Foundation 81600417China National Science Foundation 81670495National Clinical Research Center for Digestive Diseases 2015BAI13B07
6 · The paper itself

Abstract

introductionFecal microbiota transplantation (FMT) has been used as a potential treatment option for Crohn's disease (CD). However, there is still lack of safety and efficacy evidence based on large samples of CD undergoing FMT. This study aimed to evaluate the risk factors of adverse event (AE) in the long term and the efficacy of FMT in the short term for patients with CD.

methodsFMT via mid-gut for mild to severe CD in a single center trial (NCT01793831) was performed from October 2012 to December 2016. The possible factors with AE and efficacy after FMT were prospectively recorded.

resultsA total of 184 frequencies of FMT were performed for 139 patients who received FMT. During 1 month after FMT, 13.6% of mild AEs occurred, including increased frequency of defecation, fever, abdominal pain, flatulence, hematochezia, vomiturition, bloating and herpes zoster. No AE beyond 1 month was observed. Therefore, a 1 month cut-off could be suggested to define short-term and long-term AEs of FMT. Among the possible risk factors, only fecal microbiota purification methods were closely associated with the occurrence of AEs. The rate of AEs in patients undergoing manual methods for the preparation of fecal microbiota was 21.7%, which was significantly higher than the 8.7% in those experiencing an automatic method. The manual or automatic purification of fecal microbiota had no correlation with the efficacy of FMT.

conclusionThis cohort study based on the largest size of cases demonstrated that improved fecal microbiota preparation reduced the rates of AEs, but did not affect the clinical efficacy in patients with CD.

Indexed as

Crohn DiseaseFecal Microbiota TransplantationAdultChinaCohort StudiesFemaleHumansMaleMiddle AgedPatient SafetyProspective StudiesRisk AssessmentRisk FactorsSeverity of Illness IndexTimeTreatment OutcomeAdverse eventCrohn’s diseaseFecal microbiota transplantationGastroenterologySafety

Identifiers

PMID30328062
PMCPMC6223988
OpenAlexW2897641626

What OpenQuestion holds

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LicenceCC BY-NC
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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.