Objective To explore the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets (BTVBT) in blood glucose control in patients with type 2 diabetes mellitus (T2DM).Methods This study was a randomized, double-blind, placebo parallel comparison, multicentre clinical research.The subjects were T2DM patients who were using anti-hyperglycemic drugs.They were randomly divided into observation group and control group according to 1∶1 ratio.The subjects accepted the therapy of BTVBT or placebo by oral administration (3 tablets, tid) for eight weeks, followed up for 4 weeks, during which the basic treatment maintained unchanged.The primary outcomes: the changes of glycosylate hemoglobin A1c (HbA1c) from baseline.Results Totally 234 subjects (116 cases in observation group and 118 cases in control group) from 7 centers were included in the study.The baseline characteristics were comparable between these two groups.The HbA1c was (8.00±1.08)％ and (7.99±1.03)％ in observation group and control group, respectively, at baseline, and was (7.28±1.28)％ and (7.36±1.02)％ after 12 weeks of treatment [(-0.66±1.38)％ vs.(-0.64±1.14)％,P=0.914 5].The secondary outcomes were as follows: the fasting blood glucose (FBG) in the observation group were (7.91±1.87)mmol/L and (8.05±2.33)mmol/L at baseline and after 12 weeks of treatment;while in the control group, the FBG were (8.51±1.68)mmol/L and (8.00±2.02)mmol/L, and comparisons between two groups showed no significant change (P>0.05).The glycated albumin in the observation group and control group were (21.38±5.74)％ and (21.93±6.51)％ at baseline;after 4 weeks of treatment, they were (20.08±6.05)％ and (20.58±7.30)％ (the changes from baseline in these two groups were (-1.19±4.37)％ and (-1.20±5.08)％];after 8 weeks of treatment, they were (19.07±5.56)％ and (20.83±8.74)％ [the changes from baseline were (-2.09±4.51)％ and (-0.98±6.85)％];after 12 weeks of treatment, they were (19.03±5.19)％ and (19.36±6.14)％ [the changes from baseline were (-2.18±4.60)％ and (-2.47±5.20)％], there were no significant differences between two groups (P>0.05).The subgroup analysis showed that in those patients with the characteristics including body mass index (BMI)≥25 kg/m2 at baseline, the duration of diabetes mellitus longer than 8 years, fasting blood glucose less than 8 mmol/L and using insulin at baseline, the changes of HbA1c from baseline to the end of 12 weeks therapy in the observation group were more than in the control group.There were no significant differences between the two groups in terms of safety profiles, including the vital signs and laboratory findings (blood cell counts, liver function, and kidney function, all P>0.05).Conclusion Administration of BTVBT in T2DM patients for 12 weeks does not remarkably improve the HbA1c.

Objective:To analyze the composition and functional characteristics of the intestinal microflora in novel coronavirus pneumonia patients with arterial stiffness, in order to provide empirical evidence for rational use of intestinal microecological modulators.Methods:Patients with novel coronavirus pneumonia admitted to our hospital between April 5 and April 19, 2020 were enrolled as research subjects.They were divided into the stiffness group and the control group according to the results of arterial stiffness.Stool samples were collected within 7 days of admission.Intestinal flora DNA was analyzed and entered into a database, shotgun metagenomic sequencing was performed, and bioinformatics analysis was conducted based on sequencing results.Results:A total of 16 patients with novel coronavirus pneumonia were included in this study, including 7 in the stiffness group and 9 in the control group.Brachial-ankle pulse wave velocity and blood pressure were higher in the stiffness group than in the control group( P<0.05). Beta diversity analysis at the phylum level showed that there were significant differences in the composition of the intestinal flora between the two groups( P<0.05). Patients with arterial stiffness had a lower relative abundance than the controls in fecal Holdemanella, Mitsuokella, Deinococcus, Lachnospira, Turicibacter, Butyrivibrio, Sporomusa, and Halanaerobium, species associated with the production of short-chain fatty acids(SCFAs), regulation of energy metabolism, anti-radiation, anti-oxidative stress and anti-inflammatory effects.The Kyoto Encyclopedia of Genes and Genomes(KEGG)pathway enrichment analysis showed that the intestinal flora in the control group was mainly involved in the pathways of lipopolysaccharide biosynthesis, metabolism of SCFA and other amino acids, and membrane transport, while the intestinal flora in the stiffness group was mostly concerned with the pathways of amino acid metabolism and DNA damage repair. Conclusions:The use of microbial agents capable of increasing short-chain fatty acids in patients with novel caronavirus infection may contribute to the restoration of intestinal flora homeostasis.

Objective The incidence of gastrointestinal symptoms in diabetes is higher than that of non-diabetes.Thus,the aim of the present study was to observe the efficacy and safety of bifidobacterium tetragenous viable bacteria tablets in the treatment of constipation in patients with type 2 diabetes mellitus.Methods This is a multicenter,randomized,double-blind,placebo-controlled,parallel group-comparison clinical research.The subjects were randomly divided into study group and control group according to 1 ∶ 1 ratio by computer generated random number method.The subjects were either treated with bifidobacterium tetragenous viable bacteria tablets (study group) or placebo (control group) for eight weeks,and they were followed up for four weeks without changing foundation therapy for diabetes.The primary outcome was the change of complete spontaneous bowel movements (CSBMs).Results A total of 234 subjects (the study group:116 cases;the control group:118 cases) from 7 centers were included in the present study.The baseline characteristics were comparable between the two groups.In the study group,the CSBMs at 0,2,4,8 and 12 weeks were 0.0(0.0,1.0),1.0(0.5,2.0),2.0(1.0,3.0),3.0(2.0,3.5),2.0(1.0,3.0) times per week,respectively,while the CSBMs of the control group at each corresponding weeks were 0.0(0.0,1.0),1.0(0.0,1.5),1.0(0.0,1.5),1.0(0.0,2.0),1.0(0.0,1.5)times per week,respectively.There is significant difference in CSBMs between the two groups (P＜0.05).Moreover,after 12 weeks treatment,the CSBMs over spontaneous bowel movements (SBMs) ratio in the study group was higher than that in the control group [0.53 (0.40,0.67) vs 0.33 (0.00,0.50),P=0.048],indicating a more complete evacuation sensation in the study group.More subjects in the study group (66.38％) reached Bristol stool classification of normal criteria than those in the control group (48.31％,P=0.005).There were significantly improvement of bowel function index in the study group [study group 42.7 (33.3,56.7),control group 60.6 (51.7,75.7),P＜0.000 1].Furthermore,the symptoms of constipation was improved,and the satisfaction for the treatment was high in the study group.There were no significant differences of the safety indicators between the two groups.Conclusions Bifidobacterium tetragenous viable bacteria tablets can be used in patients with type 2 diabetes mellitus and constipation.Compared with placebo,it improves constipation and has no obvious adverse effects.