Evidence map›Paper›PMID 27529553›Full record

SynthesisPloS one2016

Systematic Review: Adverse Events of Fecal Microbiota Transplantation.

Sinan Wang, Mengque Xu, Weiqiang Wang, Xiaocang Cao, Meiyu Piao, Samiullah Khan, Fang Yan, Hailong Cao, Bangmao Wang

7 registry-linked trialsAbstract readSystematic Review
In one paragraph

Synthesis in PloS one, 2016. 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 216 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
216citing 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.

NCT03127696 nacompletednot on this mapstarted 2017, after this paper: background citation

A Randomised Placebo-controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Obese Subjects With Type 2 Diabetes Mellitus

TypeinterventionalSponsorChinese University of Hong KongRan2017 to 2019Enrolled61ConditionsType2 Diabetes, Type 2 Diabetes Mellitus, ObeseArmsFecal Microbiota Transplantation, Lifestyle Modification Program, Sham
NCT03183869 phase2terminatednot on this mapstarted 2017, after this paper: background citation

Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2017 to 2019Enrolled14ConditionsAutoimmune Diseases, Relapsing Multiple SclerosisArmsFecal microbiota
NCT03766321 naactive not recruitingnot on this mapstarted 2020, after this paper: background citation

Interplay Between Gut Microbiota and Adaptive Immunity in Amyotrophic Lateral Sclerosis: a Clinical Trial

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria di ModenaRan2020 to 2025Enrolled42ConditionsAmyotrophic Lateral SclerosisArmsFecal microbiota transplantation, Placebo
NCT03817125 phase1completednot on this mapstarted 2019, after this paper: background citation

A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination With Anti-PD-1 Therapy in Adult Patients With Unresectable or Metastatic Melanoma

TypeinterventionalSponsorParker Institute for Cancer ImmunotherapyRan2019 to 2022Enrolled14ConditionsMetastatic MelanomaArmsPlacebo for antibiotic, Vancomycin pretreatment, Nivolumab, Matching Placebo for SER-401, SER-401
NCT05035784 nacompletednot on this mapstarted 2020, after this paper: background citation

Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation

TypeinterventionalSponsorShengjing HospitalRan2020 to 2022Enrolled110ConditionsFecal Microbiota Transplantation, Constipation - FunctionalArmsFecal supernatant, Placebo
NCT05790356 narecruitingnot on this mapstarted 2023, after this paper: background citation

Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2023 to 2026Enrolled30ConditionsArthritis, Arthritis, Rheumatoid, Fecal Microbiota TransplantationArmsFecal Microbial transplant, Placebo capsules
NCT06290258 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.

TypeinterventionalSponsorChang Gung Memorial HospitalRan2024 to 2027Enrolled60ConditionsAutism Spectrum Disorder, Gastrointestinal Diseases, HealthyArmsFecal microbiota transplantation
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Trial
  8. Transient colonization with Blastocystis spp. after transmission via fecal microbiota transplantation.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Review
  16. Article
  17. Open forum infectious diseases · 2026
    Article
  18. Review
  19. Observational
  20. Review

156 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

9 authors.

Sinan WangDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Mengque XuDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Weiqiang WangDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Xiaocang CaoDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Meiyu PiaoDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Samiullah KhanDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Fang YanDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Hailong CaoDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.
Bangmao WangDepartment of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT.

aimTo review the AEs of FMT and to address the concerns of safety during the procedure.

methodsPublications were retrieved in the databases of Medline, Embase and Cochrane Library. AEs were classified according to their causality with FMT or their severity.

resultsA total of 7562 original articles about FMT were identified in this study, 50 of them fulfilled the inclusion criteria. Totally 78 kinds of AEs were revealed enrolled in these 50 selected publications. The total incidence rate of AEs was 28.5%. Among the 42 publications, 5 kinds were definitely and 38 kinds were probably related to FMT. The commonest FMT-attributable AE was abdominal discomfort, which was reported in 19 publications. For upper gastrointestinal routes of FMT, 43.6% (89/204) patients were compromised by FMT-attributable AE, while the incidence dropped to 17.7% (76/430) for lower gastrointestinal routes. In contrast, the incidences of serious adverse events (SAEs) were 2.0% (4/196) and 6.1% (40/659) for upper and lower gastrointestinal routes, respectively. A total of 44 kinds of SAEs occurred in 9.2% patients, including death (3.5%, 38/1089), infection (2.5%, 27/1089), relapse of inflammatory bowel diseases (0.6%, 7/1089) and Clostridium difficile infection (0.9%, 10/1089).

conclusionConsequently, both AEs and SAEs are not rare and should be carefully monitored throughout FMT. However, high quality randomized controlled trials are still needed for the more definite incidence of AEs of FMT.

Indexed as

Fecal Microbiota TransplantationHumansSafety

Identifiers

PMID27529553
PMCPMC4986962

What OpenQuestion holds

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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.