Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF Trial.

BACKGROUND: Inhaled glucocorticoid corticosteroid (ICS), long-acting ß2-adrenoceptor agonist (LABA), and other drugs have limited therapeutic effects on COPD with significant individual differences. Traditional Chinese medicine (TCM)-modified Bushen Yiqi formula (MBYF) demonstrates advantages in COPD management in China. This study aims to evaluate the efficacy and safety of MBYF as an add-on to budesonide/formoterol in COPD patients and confirm the related genes affecting the therapeutic effect in the treatment of COPD. METHODS: In this multicentre, randomised, double-blind, placebo-controlled, parallel-group study, eligible patients with COPD will randomly receive a 360-day placebo or MBYF as an adjuvant to budesonide/formoterol in a 1:1 ratio and be followed up with every 2 months. The primary outcomes will be the frequency, times, and severity of acute exacerbation of COPD (AECOPD), COPD assessment test (CAT) score, and pulmonary function tests (PFTs). The secondary outcomes will include the modified Medical Research Council (mMRC) dyspnoea scale, 6-min walking test (6MWT), BODE index, quantitative scores of syndromes classified in TCM, inflammation indices, and hypothalamic-pituitary-adrenaline (HPA) axis function. We will also test the genotype to determine the relationship between drugs and efficacy. All the data will be recorded in case report forms (CRFs) and analysed by SPSS V.20.0. DISCUSSION: A randomized clinical trial design to evaluate the efficacy and safety of MBYF in COPD is described. The results will provide evidence for the combination therapy of modern medicine and TCM medicine, and individual therapy for COPD. TRIAL REGISTRATION: ID:  ChiCTR1900026124 , Prospective registration.

Dietary fiber isolated from sweet potato residues promotes a healthy gut microbiome profile.

This study investigated the impact of dietary fiber from sweet potato residue (SPDF) on the diversity of the gut microbiota. An in vitro batch culture system simulating the human gut was used to understand the prebiotic role of SPDF. The results showed that SPDF mediated a significant increase in the concentrations of Bifidobacterium and Lactobacillus, whereas induced a significant decrease of Enterobacillus, Clostridium perfringens and Bacteroides. The prebiotic index and Bifidobacterium/Enterobacillus value were also significantly increased in SPDF groups compared to those of the control group, suggesting that SPDF had prebiotic effects. Furthermore, to investigate the effects of SPDF on the intestinal microecosystem, diets containing different concentrations of SPDF were used to feed Wistar rats for 4 weeks. 16S rRNA gene sequencing, short chain fatty acid quantification and physiochemical property analysis in the rat feces were then conducted. The results showed that SPDF significantly increased the Bacteroidetes to Firmicutes ratio at the phylum level and the amount of Akkermansia was also increased at the genus level, which was confirmed by qRT-PCR. The production of propionate and butyrate in the rat feces of both 3% and 15% SPDF groups was higher than that in the control group, which was further confirmed by the decrease of pH. Additionally, SPDF supplementation in this study resulted in a higher villus height to fossa depth ratio, which indicated improved digestion and absorption in the GI tract. Our findings support the utilization of SPDF from sweet potato residue in the development of potentially prebiotic food products for improving intestinal health.