Verma Arushi, Nelson Maria T, DePaolo William R, Hampe Christiane, Roth Christian L
Department of Pediatrics, University of Washington, Seattle, WA USA.
Division of Pediatric Endocrinology, Seattle Children's Hospital, Seattle, WA USA.
J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec.
The purpose of the study is to assess the effect of probiotic supplementation on gut microbiota and insulin resistance in adolescents with severe obesity.
Through a randomized, double blind, placebo-controlled, 12-week pilot clinical trial, 15 adolescents with severe obesity received either an oral probiotic 'Visbiome®' ( = 8) or placebo ( = 7). Anthropometry, fasting glucose, insulin, hs-CRP and stool for microbiome and calprotectin were collected at baseline (week 0) and 12 weeks after intervention.
Among completers ( = 4 in each of the two groups), mean change in fasting glucose was significantly lower in the probiotic group (0 ± 4 mg/dL) as compared to the placebo group (6.3 ± 1.7 mg/dL) ( = 0.028). Gut microbial Firmicutes to Bacteroidetes (F/B) ratio had a greater decline from week 0 to week 12 in the probiotic group (mean 17.7 ± 25.1 to 2.39 ± 2.0, respectively) but was not statistically significant ( = 0.06) as compared to in the placebo group (mean 12.8 ± 18.2 to 6.9 ± 5.61, respectively) ( = 0.89). Weight and BMI (mean ± SD) trended to remain stable in the treatment group (-1.07 ± 6.1 kg and -0.3 ± 2.2 kg/m respectively) as compared to the placebo group (3.9 ± 5.1 kg, 1.0 ± 1.6 kg/m) but was not significant ( = 0.12 for weight and 0.38 for BMI). No significant change in the fasting insulin, HOMA-IR, or serum and stool inflammatory markers were noted between the two groups ( > 0.05). One participant in the treatment arm reported adverse effects of gastrointestinal intolerance.
Probiotic therapy with Visbiome® may improve the fasting glucose and possibly decrease the gut microbial F/B ratio as compared to placebo in adolescents with severe obesity. Future larger studies are required to confirm these findings.: NCT03109587.
The online version contains supplementary material available at 10.1007/s40200-021-00855-7.
本研究旨在评估补充益生菌对重度肥胖青少年肠道微生物群和胰岛素抵抗的影响。
通过一项随机、双盲、安慰剂对照的12周临床试验，15名重度肥胖青少年接受了口服益生菌“Visbiome®”（n = 8）或安慰剂（n = 7）。在基线（第0周）和干预后12周收集人体测量数据、空腹血糖、胰岛素、高敏C反应蛋白以及用于微生物组和钙卫蛋白检测的粪便样本。
在完成试验者中（两组各4名），益生菌组的空腹血糖平均变化（0±4mg/dL）显著低于安慰剂组（6.3±1.7mg/dL）（P = 0.028）。从第0周到第12周，益生菌组肠道微生物厚壁菌门与拟杆菌门（F/B）的比例下降幅度更大（分别从平均17.7±25.1降至2.39±2.0），但与安慰剂组（分别从平均12.8±18.2降至6.9±5.61）相比，差异无统计学意义（P = 0.06）（P = 0.89）。与安慰剂组（体重增加3.9±5.1kg，体重指数增加1.0±1.6kg/m²）相比，治疗组的体重和体重指数（均值±标准差）有保持稳定的趋势（分别下降1.07±6.1kg和0.3±2.2kg/m²），但差异无统计学意义（体重P = 0.12，体重指数P = 0.38）。两组之间的空腹胰岛素、稳态模型评估胰岛素抵抗（HOMA-IR）或血清及粪便炎症标志物均无显著变化（P>0.05）。治疗组有一名参与者报告了胃肠道不耐受的不良反应。
与安慰剂相比，使用Visbiome®进行益生菌治疗可能改善重度肥胖青少年的空腹血糖，并可能降低肠道微生物F/B比例。未来需要更大规模的研究来证实这些发现。试验注册号：NCT03109587。
在线版本包含可在10.1007/s40200-021-00855-7获取的补充材料。
