Evidence map›Paper›PMID 26363929›Full record

ArticleJournal of translational medicine2015

Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis.

Bota Cui, Pan Li, Lijuan Xu, Youquan Zhao, Huiquan Wang, Zhaoyuan Peng, Hai'e Xu, Jie Xiang, Zhi He, Ting Zhang and 5 more

7 registry-linked trialsAbstract read
In one paragraph

Article in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 90 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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
NCT02575040 phase3unknown statusnot on this map

Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease

TypeinterventionalSponsorSaglik Bilimleri Universitesi Gulhane Tip FakultesiRan2015 to 2020Enrolled60ConditionsUlcerative Colitis, Crohn Disease, Constipation (Excl Faecal Impaction)ArmsFecal microbiota transplantation
NCT02998112 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2016 to 2017Enrolled188ConditionsUlcerative ColitisArmsfecal microbiota transplantation, Saline
NCT03335982 naunknown statusnot on this map

Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2015 to 2017Enrolled100ConditionsTransendoscopic Enteral TubingArmstransendoscopic enteral tubing in mid-gut
NCT03483246 phase3active not recruitingnot on this mapstarted 2018, after this paper: background citation

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2027Enrolled150ConditionsUlcerative ColitisArmsFecal Microbiota Transplantation (FMT), Sham-transplantation Placebo
NCT03804931 phase2 / phase3recruitingnot on this mapstarted 2019, after this paper: background citation

Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

TypeinterventionalSponsorGuangzhou First People's HospitalRan2019 to 2030Enrolled120ConditionsUlcerative Colitis, Fecal Microbiota TransplantationArmsFecal microbiota transplantation, Infusion of Saline, 5-Aminosalicylic acid(5-ASA) and/or Prednisone
NCT04997733 phase3recruitingnot on this mapstarted 2021, after this paper: background citation

Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2021 to 2029Enrolled150ConditionsCrohn DiseaseArmsFecal Microbiota Transplantation (FMT), Sham-transplantation (placebo)
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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30 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

15 authors.

Bota CuiMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. cuibota@163.com.
Pan LiMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. puddyli@hotmail.com.
Lijuan XuMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. Ljxu_njmu@163.com.
Youquan ZhaoCollega of Precision Instrument and Opto-electronics Engineering, Tianjin University, 92 Weijin Road, 300072, Tianjin, China. sea7man@sina.com.
Huiquan WangBiomedical Engineering Department, School of Electronics and Information Engineering, Tianjin Polytechnic University, 399 Binshui West Street, 300378, Tianjin, China. huiquan85@gmail.com.
Zhaoyuan PengMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. zhaoyouquan@tju.edu.cn.
Hai'e XuClinical Nutrition, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. maiexu@126.com.
Jie XiangMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. 812862173@qq.com.
Zhi HeMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. hezhi0312@163.com.
Ting ZhangMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. 386962565@qq.com.
Yongzhan NieState Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, 710032, Xi'an, China. yongznie@fmmu.edu.cn.
Kaichun WuState Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, 710032, Xi'an, China. kaicwu@fmmu.edu.cn.
Daiming FanState Key Laboratory of Cancer Biology and Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, 710032, Xi'an, China. fandaim@fmmu.edu.cn.
Guozhong JiMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. jgz@njmu.edu.cn.
Faming ZhangMedical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, 121 Jiangjiayuan, 210011, Nanjing, China. fzhang@njmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe strategy of using fecal microbiota transplantation (FMT) for refractory ulcerative colitis (UC) remains unclear if single FMT failed to induce remission. This study aimed to evaluate the efficacy and safety of a designed step-up FMT strategy for the steroid-dependent UC.

methodsFifteen patients with steroid-dependent UC were enrolled, and treated with step-up FMT strategy. Follow-up clinical data was collected for a minimum of 3 months. Fecal microbiota composition before and post FMT of patients and related donors were analyzed by 16S rRNA sequencing.

resultsEight of fourteen (57.1 %) patients achieved clinical improvement and were able to discontinue steroids following step-up FMT. One patient was lost to follow-up. Among the 8 patients who responded, five (35.7 %) received one FMT therapy, one (7.1 %) received two FMTs, and two (14.2 %) received two FMTs plus a scheduled course of steroids. Four (28.6 %) of the 8 patients who responded maintained long-term remission during follow-up (3-18 months). Six patients (42.9 %) failed to meet the criteria of clinical improvement and maintained steroid dependence, though three experienced transient or partial improvement. Microbiota analysis showed that FMT altered the composition greatly, and a microbiota composition highly similar to that of the donor emerged in the patients with successful treatment. No severe adverse events occurred during treatment and follow-up.

conclusionsStep-up FMT strategy shows promise as a therapeutic strategy for patients with steroid-dependent UC, likely due to the successful restructuring of gut microbial composition.

trial registrationClinicalTrials.gov, Number NCT01790061.

Indexed as

Fecal Microbiota TransplantationAdolescentAdrenal Cortex HormonesAdultChildColitis, UlcerativeFecesFemaleHumansMaleMicrobiotaMiddle AgedPilot ProjectsProspective StudiesSpecimen HandlingTreatment OutcomeAdrenal Cortex Hormones

Identifiers

PMID26363929
PMCPMC4567790

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Registered trials

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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.