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.

The effect of assertive case management on relapse and health economic evaluation in schizophrenics living in communities / 中国神经精神疾病杂志

Objective To evaluate the effect of assertive case management on relapse and health economic evalua?tion in schizophrenics living in communities. Methods Two hundred outpatients were randomly divided into the study group (107 enrolled, 107 completed) which received assertive case management and the control group (93 enrolled, 91 completed) which received normal management treatment for 12 months. Clinical global impression scale (CGI) and the cost of treatment were assessed every three months. Medication adherence and family burden were evaluated before treat?ment and 3, 6 and 12 months after the treatment using Medication Adherence Rating Scale (MARS) and Family Burden Instructing, respectively. Results The study group was less likely to relapse compared with the control group over the 12-month follow-up and the relapse rates were 1.9%and 11.0%in study and control groups, respectively (P<0.01). The repeated-measures analysis of variance indicated that time main effect was significant in severity of illness factor score of CGI (P<0.01). The time main effect and group main effect in factor 1 and factor 3 scores of MARS were significant (all P<0.05) and there was an interaction effect in factor1 score of MARS (P<0.01). In the study group, time effect were signifi?cant in factor 1 score of MARS (P<0.01). The time main effects in indirect cost and total cost were significant and so were interaction effects in direct cost and total cost (P<0.05). In the study group, time effects were significant in direct cost and total cost (P<0.01). Comparison of FBI dimensions before and after the intervention showed that family relation?ship was much more decreased in the study group than in the control group (P<0.01). Conclusions Assertive Case Man?agement can reduce the recurrence of schizophrenia living in communities, improve compliance medication and family re?lationship as well as reduce the cost of treatment.