创作:szx 审核:szx 2020年12月31日
  • 87名肥胖青少年(BMI≥30)随机分为2组,42名口服粪菌胶囊(来自4名健康供体),45名口服安慰剂,单次干预后随访26周;
  • 干预6周后,两组之间的BMI无显著差异,粪菌移植组的男性型/女性型脂肪在干预后6、12及26周均显著降低;
  • 粪菌移植对胰岛素抵抗、肝功能、脂质、炎症标志物、血压、总体脂比、肠道健康、健康相关生活质量等指标均无显著影响;
  • 粪菌移植组的肠道菌群组成变化可维持12周;
  • 干预26周后,粪菌移植可显著缓解代谢综合征。
JAMA Network Open上发表的一项RCT研究结果,对87名肥胖青少年(14-18岁)进行单次粪菌移植干预(口服粪菌胶囊),粪菌移植无法显著降低BMI,且未能改善胰岛素抵抗、肝功能、炎症、血压、体脂、生活质量等指标,但能够更好地改善代谢综合征。
JAMA Network Open [IF:5.032]

Effects of Fecal Microbiome Transfer in Adolescents With Obesity - The Gut Bugs Randomized Controlled Trial



2020-12-21, Article

Abstract & Authors:展开

Importance: Treatment of pediatric obesity is challenging. Preclinical studies in mice indicated that weight and metabolism can be altered by gut microbiome manipulation.
Objective : To assess efficacy of fecal microbiome transfer (FMT) to treat adolescent obesity and improve metabolism.
Design, Setting, and Participants : This randomized, double-masked, placebo-controlled trial (October 2017-March 2019) with a 26-week follow-up was conducted among adolescents aged 14 to 18 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 30 or more in Auckland, New Zealand. A total of 87 individuals took part—565 individuals responded to advertisements, 328 were ineligible, and 150 declined participation. Clinical data were analyzed from September 2019 to May 2020.
Interventions: Single course of oral encapsulated fecal microbiome from 4 healthy lean donors of the same sex or saline placebo.
Main Outcomes and Measures : Primary outcome was BMI standard deviation score at 6 weeks using intention-to-treat analysis. Secondary outcomes included body composition, cardiometabolic parameters, well-being, and gut microbiome composition.
Results: Eighty-seven participants (59% female adolescents, mean [SD] age 17.2 [1.4] years) were randomized 1:1, in groups stratified by sex, to FMT (42 participants) or placebo (45 participants). There was no effect of FMT on BMI standard deviation score at 6 weeks (adjusted mean difference [aMD] −0.026; 95% CI −0.074, 0.022). Reductions in android-to-gynoid-fat ratio in the FMT vs placebo group were observed at 6, 12, and 26 weeks, with aMDs of −0.021 (95% CI, −0.041 to −0.001), −0.023 (95% CI, −0.043 to −0.003), and −0.029 (95% CI, −0.049 to −0.008), respectively. There were no observed effects on insulin sensitivity, liver function, lipid profile, inflammatory markers, blood pressure, total body fat percentage, gut health, and health-related quality of life. Gut microbiome profiling revealed a shift in community composition among the FMT group, maintained up to 12 weeks. In post-hoc exploratory analyses among participants with metabolic syndrome at baseline, FMT led to greater resolution of this condition (18 to 4) compared with placebo (13 to 10) by 26 weeks (adjusted odds ratio, 0.06; 95% CI, 0.01-0.45; P = .007). There were no serious adverse events recorded throughout the trial.
Conclusions and Relevance: In this randomized clinical trial of adolescents with obesite, there was no effect of FMT on weight loss in adolescents with obesity, although a reduction in abdominal adiposity was observed. Post-hoc analyses indicated a resolution of undiagnosed metabolic syndrome with FMT among those with this condition. Further trials are needed to confirm these results and identify organisms and mechanisms responsible for mediating the observed benefits.

First Authors:
Karen S W Leong

Correspondence Authors:
Justin M O Sullivan,Wayne S Cutfield

All Authors:
Karen S W Leong,Thilini N Jayasinghe,Brooke C Wilson,José G B Derraik,Benjamin B Albert,Valentina Chiavaroli,Darren M Svirskis,Kathryn L Beck,Cathryn A Conlon,Yannan Jiang,William Schierding,Tommi Vatanen,David J Holland,Justin M O Sullivan,Wayne S Cutfield