Retrospective Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Dec 26, 2018; 6(16): 1121-1127
Published online Dec 26, 2018. doi: 10.12998/wjcc.v6.i16.1121
Safety of fecal microbiota transplantation in Chinese children: A single-center retrospective study
Xin-Yue Zhang, Yi-Zhong Wang, Xiao-Lu Li, Hui Hu, Hai-Feng Liu, Dan Li, Yong-Mei Xiao, Ting Zhang
Xin-Yue Zhang, Yi-Zhong Wang, Xiao-Lu Li, Hui Hu, Hai-Feng Liu, Dan Li, Yong-Mei Xiao, Ting Zhang, Department of Gastroenterology, Hepatology and Nutrition, Shanghai Children’s Hospital, Shanghai Jiao Tong University, Shanghai 200040, China
Author contributions: All authors helped to perform the research; Zhang XY contributed to writing the manuscript and performing the procedures and data analysis; Wang YZ contributed to manuscript writing, study conception and design, and data analysis; Li XL contributed to writing the manuscript and collecting the data; Hu H, Liu HF, Li D and Xiao YM contributed to patient recruitment, diagnosis, and treatment; Zhang T contributed to writing the manuscript, study conception and design, cohort setting, and patient management.
Supported by Shanghai Hospital Development Center New Frontier Technology Joint Research Project, No. SHDC12017115.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Shanghai Children’s Hospital (2014RY015-E02).
Informed consent statement: Written informed consent was obtained from parents or legal guardians of all pediatric subjects.
Conflict-of-interest statement: All authors declare no conflicts of interest related to this article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author to: Ting Zhang, PhD, Professor, Department of Gastroenterology, Hepatology and Nutrition, Shanghai Children’s Hospital, Shanghai Jiao Tong University, No. 355, Luding Road, Shanghai 200062, China. zhangt@shchildren.com.cn
Telephone: +86-21-52976338 Fax: +86-21-52976338
Received: October 15, 2018
Peer-review started: October 15, 2018
First decision: November 7, 2018
Revised: November 22, 2018
Accepted: November 30, 2018
Article in press: December 1, 2018
Published online: December 26, 2018
Processing time: 70 Days and 11.7 Hours
ARTICLE HIGHLIGHTS
Research background

Fecal microbiota transplantation (FMT) is the administration of fecal bacterial liquid from healthy donors to a recipient’s digestive tract, which is recommended as a therapeutic method for recurrent Clostridium difficile infection (CDI). Many clinical trials focusing on different diseases are in progress. To date, scarce research and long-term follow-up data have been conducted on FMT in children or on the proper guidelines. Our center first performed FMT to treat a 13-month-old boy with severe CDI in 2013. Until February 2018, our center had performed 114 pediatric FMT procedures in 49 subjects. We here retrospectively evaluated the safety of these procedures and analyzed the adverse events (AEs).

Research motivation

To investigate the safety of FMT in children.

Research objectives

To evaluate the adverse events occurring during and after the procedure of FMT.

Research methods

Forty-nine patients at Shanghai Children’s Hospital from November 2013 to February 2018 were recruited into our retrospective analysis. All FMT processes followed uniform standards. AEs related to FMT were divided into short-term (48 h post-FMT) and long-term (3 mo). All potential factors influencing AEs, such as gender, age, time of FMT infusion, route of administration, disease type, immune function state, and donor relative genetic background, were analyzed as independent factors. The significant independent factors and risk ratio with 95% confidence interval (CI) were assessed by multivariate logistic regression analysis.

Research results

Forty-nine patients (mean age 68.1 mo, range 4 to 193) were recruited. Their average follow-up time after the first FMT was 23.1 mo. The incidence of short-term AEs was 26.32% (30/114). The most common short-term AEs were abdominal pain, diarrhea, fever, and vomiting, which were all self-limited and symptom-free within 48 h. Two severe AEs occurred, and one patient died in the fourth week after FMT. All-cause mortality was 2.04%. As independent factors, age (P = 0.006) and immune state (P = 0.002) had significant effects. Age greater than 72 mo seemed to be correlated with more AEs than age 13 to 36 mo (P = 0.04). In multivariate logistic regression analysis, immune state was an independent risk factor for AE occurrence (P = 0.035), and the risk ratio in immunodeficient patients was 3.105 (95%CI: 1.080-8.923).

Research conclusions

FMT was proven to be tolerated and safe in children. However, we need to be more cautious with immunodeficient patients. The effect on children’s long-term health is unpredictable.

Research perspectives

FMT was well tolerated and safe in children, while more data for immunodeficient pediatric patients are required.