Zhang Xin-Yue, Wang Yi-Zhong, Li Xiao-Lu, Hu Hui, Liu Hai-Feng, Li Dan, Xiao Yong-Mei, Zhang Ting
Department of Gastroenterology, Hepatology and Nutrition, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai 200040, China.
World J Clin Cases. 2018 Dec 26;6(16):1121-1127. doi: 10.12998/wjcc.v6.i16.1121.
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 infection (CDI). Many clinical trials focusing on different diseases are in progress. To date, scarce research and long-term follow-up 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.
To investigate the safety of FMT in children.
A retrospective study was conducted on 49 patients who underwent 114 FMT treatments at our hospital. All FMT processes followed uniform standards. Adverse events (AEs) related to FMT were divided into short-term (48 h post-FMT) and long-term (3 mo). All potential influencing factors for 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.
Forty-nine patients (mean age 68.1 mo, range 4 to 193 mo) 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 ( = 0.006) and immune state ( = 0.002) had significant effects. Age greater than 72 mo seemed to be correlated with more AEs than age 13 to 36 mo ( = 0.04). In multivariate logistic regression analysis, immune state was an independent risk factor for AE occurrence ( = 0.035), and the risk ratio in immunodeficient patients was 3.105 (95%CI: 1.080-8.923).
Although FMT was proven to be tolerated in children, we need to be more cautious with immunodeficient patients. The effect on children's long-term health is unpredictable.
粪菌移植（FMT）是将健康供体的粪便菌液输注到受体消化道，被推荐作为复发性艰难梭菌感染（CDI）的一种治疗方法。许多针对不同疾病的临床试验正在进行。迄今为止，针对儿童粪菌移植或适当指南的研究及长期随访较少。2013年，我们中心首次对一名13个月大的重症CDI男孩进行了粪菌移植。截至2018年2月，我们中心已对49名受试者进行了114例儿科粪菌移植手术。
探讨粪菌移植在儿童中的安全性。
对在我院接受114次粪菌移植治疗的49例患者进行回顾性研究。所有粪菌移植过程均遵循统一标准。与粪菌移植相关的不良事件（AE）分为短期（粪菌移植后48小时内）和长期（3个月）。将所有不良事件的潜在影响因素，如性别、年龄、粪菌移植输注时间、给药途径、疾病类型、免疫功能状态和供体相关遗传背景，作为独立因素进行分析。通过多因素logistic回归分析评估显著的独立因素和95%置信区间（CI）的风险比。
招募了49例患者（平均年龄68.1个月，范围4至193个月）。首次粪菌移植后的平均随访时间为23.1个月。短期不良事件的发生率为26.32%（30/114）。最常见的短期不良事件是腹痛、腹泻、发热和呕吐，这些均为自限性，在48小时内症状消失。发生了2例严重不良事件，1例患者在粪菌移植后第四周死亡。全因死亡率为2.04%。作为独立因素，年龄（P = 0.006）和免疫状态（P = 0.002）有显著影响。年龄大于72个月似乎比13至36个月的年龄与更多不良事件相关（P = 0.04）。在多因素logistic回归分析中，免疫状态是不良事件发生的独立危险因素（P = 0.035），免疫缺陷患者的风险比为3.105（95%CI：1.080 - 8.923）。
虽然粪菌移植在儿童中被证明是可耐受的，但对于免疫缺陷患者我们需要更加谨慎。对儿童长期健康的影响是不可预测的。
