FTACMT study protocol: a multicentre, double-blind, randomised, placebo-controlled trial of faecal microbiota transplantation for autism spectrum disorder.

INTRODUCTION: Autism spectrum disorder (ASD) is a complicated diffuse developmental disorder that commonly involves gastrointestinal distress and dysbacteriosis. Emerging lines of evidence have shown faecal microbiota transplantation (FMT) to be a potential therapeutic strategy for improving the clinical outcomes of patients with ASD by re-establishing their intestinal microflora. We are undertaking the first-ever multicentre, double-blind, randomised controlled trial of FMT for the treatment of children with both ASD and gastrointestinal symptoms and will assess the feasibility and efficacy outcomes of this strategy. METHODS: In total, 318 children with both ASD and gastrointestinal symptoms will be enrolled (from 15 hospitals in China) to receive either FMT intervention (n=212) or a placebo (control, n=106). Children aged 3-6 years will take two capsules two times a day, and those older than 6 years will take three capsules two times a day. Each patient will receive four treatment courses, with each 12-day course being repeated every month. Outcomes will be evaluated at baseline, throughout the period of intervention, and at subsequent follow-ups for 2 months. The primary trial objective is to investigate the remodelling effect of FMT on the intestinal microflora in patients with ASD. The secondary objective focuses on the clinical efficacy and safety of FMT, including its improvement of the clinical response and metabonomics. ETHICS AND DISSEMINATION: Ethical approval was obtained from the hospital Ethics Committee of each Faecal Transfer for ASD China Multicenter Trial Working Group. The ongoing FMT clinical trial is intended to support the approval of the new technology and its administration. The results of this trial will provide high-quality evidence to inform the future clinical application of this new therapy. TRIAL REGISTRATION NUMBER: ChiCTR2100043906; Pre-results.

Force Transmission Mode of Foot Ankle in Children with Down’s Syndrome During Standing / 医用生物力学

Objective To explore the joint contact force, ligament tensile force and force transmission mode of foot internal structure in Down’s syndrome child (DSC) during standing. Methods The finite element models of foot were constructed based on CT image data from one DSC and one typically developing child (TDC). The models were validated by plantar pressure measurement during static standing. To simulate foot force during standing, the ground reaction force and the triceps surae force were applied as the loading condition. Contact pressure of the tibiotalar, talonavicular and calcaneocuboid joints, tensile force of the spring and plantar calcaneocuboid ligaments, and force transmission mode in transverse tarsal joints were calculated and analyzed. Results The finite element models of foot were validated to be reliable. Compared with the TDC, the DSC showed higher contact pressure at the tibiotalar joint and lower contact pressure at the talonavicular joint. The tensile force of spring and plantar calcaneocuboid ligaments of DSC was 10 times and 58 times of TDC, respectively. The forces transmitted through both mediate and lateral columns in DSC were lower than those in TDC. Conclusions Abnormal contact pressure of the tibiotalar joint, larger tensile force of midfoot ligaments and smaller force of the transverse tarsal joint were found in DSC during standing. The abnormal alteration of stress patterns in foot internal structure of DSC should be fully considered in clinical rehabilitation, so as to provide theoretical references for screening and making intervention plans for early rehabilitation, as well as designing individualized orthopedic insoles.

Research Overview of Clinical Application of TCM Powders in Digestive System Diseases / 中国中医药信息杂志

Powder is a powdery medicine dispensed in the form of a pulverized medicine from one or multiple Chinese herbal medicines, which has been recorded in theHuang Di Nei Jing (Huangdi’s Canon of Medicine),the earliest Chinese medical classic. TCM powder is widely used in various subjects by clinical TCM practitioners, especially in digestive system diseases. This article overviewed the clinical researches on the application of TCM powder in digestive system diseases, which could provide comprehensive references for further studies of TCM powder in the treatment of digestive system diseases and perfect its application in clinical studies.