title: The effects of co-administration of probiotics with herbal medicine on obesity, metabolic endotoxemia and dysbiosis: a randomized double-blind controlled clinical trial.
abstract: OBJECTIVE
  Probiotics help maintain balance in composition of the gut microbiota, and have been considered as a potential treatment for obesity. This study was conducted in order to assess the effects of probiotics when combined with herbal medicine in treatment of obesity. Probiotics were tested for the ability to modulate gut microbiota, gut permeability, and endotoxin level, which may have correlation with factors involved in obesity.
  
  
  METHODS
  A randomized, double-blind, placebo controlled study was conducted, in which patients with higher BMI (>25 kg/m(2)) and waist circumference (>85 cm) were enrolled and randomly assigned to receive Bofutsushosan with either probiotics or placebo capsules for a period of eight weeks. Assessment of body composition parameters, metabolic biomarkers, endotoxin level, gut permeability, and fecal bacteria in stool was performed at baseline and at week 8. The study was registered at the Clinical Research Information Service, approved by the Korea National Institute of Health (KCT0000386).
  
  
  RESULTS
  Although both groups showed a significant reduction in weight and waist circumference (p = 0.000), no significant differences in body composition and metabolic markers were observed. In correlation analysis, change in body composition showed positive correlation with endotoxin level (r = 0.441, p < 0.05 for BW; and r = 0.350, p < 0.05 for fat mass) and the population of gut Lactobacillus plantarum (r = 0.425, p < 0.05 for BW; and r = 0.407, p < 0.05 for BMI). The Gram negative bacterial population in gut also exhibited positive correlation with changes in body composition (WC) and total cholesterol level (r = 0.359, and 0.393, for the former and later parameters, respectively, p < 0.05 for both). While, the profile of gut Bifidobacterium breve population showed negative correlation with endotoxin level (r = -0.350, p < 0.05).
  
  
  CONCLUSIONS
  Correlations between gut microbiota and change in body composition indicate that probiotics may influence energy metabolism in obesity. Correlation between endotoxin level and weight reduction indicates that probiotics may play an important role in prevention of endotoxin production, which can lead to gut microbiota dysbiosis associated with obesity.
authors.affiliation: Department of Oriental Medicine, Dongguk University, Gyeongju, Republic of Korea.
authors.forename: Sin Ji
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: College of Pharmacy, Dongguk University - Seoul, Goyang, Republic of Korea.
authors.forename: Shambhunath
authors.initials: S
authors.lastname: Bose
authors.affiliation: Cell Biotech Co., Ltd., Gimpo, Republic of Korea.
authors.forename: Jae-Gu
authors.initials: JG
authors.lastname: Seo
authors.affiliation: Cell Biotech Co., Ltd., Gimpo, Republic of Korea.
authors.forename: Won-Seok
authors.initials: WS
authors.lastname: Chung
authors.affiliation: Department of Medicine, Graduate School, Dongguk University - Seoul, Republic of Korea.
authors.forename: Chi-Yeon
authors.initials: CY
authors.lastname: Lim
authors.affiliation: Department of Oriental Medicine, Dongguk University, Gyeongju, Republic of Korea. Electronic address: kimklar@dongguk.ac.kr.
authors.forename: Hojun
authors.initials: H
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D001823:Body Composition; D015992:Body Mass Index; D004311:Double-Blind Method; D064806:Dysbiosis / Q000628:therapy*; D019446:Endotoxemia / Q000628:therapy*; D004731:Endotoxins / Q000032:analysis; D005243:Feces / Q000382:microbiology; D005260:Female; D041981:Gastrointestinal Tract / Q000382:microbiology; D006801:Humans; D064307:Microbiota; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D008517:Phytotherapy; D019936:Probiotics / Q000008:administration & dosage*; D011788:Quality of Life; D056910:Republic of Korea; D016896:Treatment Outcome; D055105:Waist Circumference; D015431:Weight Loss; D055815:Young Adult
chemical_list: D004731:Endotoxins
keywords: Endotoxin; Gut microbiota; Metabolic disorders; Obesity; Probiotics