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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.
Subject(s)
Autism Spectrum Disorder , Gastrointestinal Microbiome , Autism Spectrum Disorder/etiology , Autism Spectrum Disorder/therapy , Child , Child, Preschool , Double-Blind Method , Fecal Microbiota Transplantation/methods , Feces , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
Objective To explore the structure changes of white matter in the first-episode schizo-phrenic patients with never-medicated(FESZ)and the relationship between facial emotion perception and white matter(WM)integrity.Methods Sixty-three schizophrenic patients and thirty health control subjects underwent diffusion tensor imaging(DTI)scans.Voxel-based analysis was used to compared fractional ani-sotropy(FA)map between the two groups.Correlations were analyzed with pearson relative analysis between impaired facial emotion perception tested by facial emotion categorization(FEC)and severity of symptoms measured by the Positive and Negative Syndrome Scale(PANSS).Results (1)Compared with controls, FESZ patients showed overall decreased FA in WM of the body of left ventral frontal lobe((MNI(x,y,z):-18,26,-4;t=4.43)),right supramarginal gyrus((MNI(x,y,z):32,-50,26;t=4.27)),left middle oc-cipital gyral((MNI(x,y,z):-26,-60,0;t=4.89)),right middle occipital gyral((MNI(x,y,z):28,-70, 14;t=4.18)),left fusiform gyrus((MNI(x,y,z):-40,-50,0;t=3.92)),left cerebellum anterior lobe ((MNI(x,y,z):-32,-56,-28;t=4.57)),right parahippocampa gyrus1((MNI(x,y,z):32,-10,-14;t=4.16)),right parahippocampa gyrus2((MNI(x,y,z):16,-6,-14;t=4.56)),left anterior cingulate ((MNI(x,y,z):-2,4,-6;t=4.41)),left extra-nuclear((MNI(x,y,z):-2,-10,-6;t=4.44)),right thalamus((MNI(x,y,z):10,-10,2;t=4.20)),left thalamus((MNI(x,y,z):-22,-28,12;t=4.01)), and right caudate((MNI(x,y,z):14,12,8;t=4.87)).(2)Compared with controls,the patients with schizo-phrenia showed a higher shift point and a steeper slope than control subjects in FEC.Correlational analysis re-vealed that the negative correlations were found between the slope and negative factor(r=-0.298,P=0.036),between positive factor and the FA value in WM of the right middle occipital gyral(r=-0.322,P=0.023)and the left middle occipital gyral(r=-0.288,P=0.043),and between the FA value in the left cere-bellum anterior lobe and shift point(r=-0.393,P=0.005),but the positive correlation was found between disorganized/concrete factor and the FA value in the right parahippocampal gyrus(r=0.429,P=0.002).Con-clusions There are extensive microstructural abnormalities in WM of patients with FESZ.Disrupted WM in-tegrity in these regions may constitute a potential neural pathological basis for the facial emotion perception impairments in schizophrenia.
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Objective To quantitatively assess renal hemodynamic changes in hypertensive acute kidney injury in rabbits induced by L-NAME using 64-slice spiral CT functional imaging techniques,and to explore the application of these techniques in evaluation of early kidney functional changes.Methods Fourteen female New Zealand white rabbits were randomly divided into normal control group (n=6)and L-NAME group (n=8).The control group was injected NaCl solution and the L-NAME group was injected the same amount of L-NAME solution to make hypertensive acute kidney injury model.64-slice spiral CT and SPECT were scanned af-ter injection.Blood samples were collected before and after injecting NaCl and L-NAME solution to detect serum creatinine (Cr).Cr level and CT perfusion parameters of the two groups were analyzed and compared with the pathology results.GFRCT detected by con-trast-enhanced CT and GFRSPECT detected by SPECT were analyzed by the rank correlation test.Results Renal blood volume,blood flow,permeability surface,time to peak,and peak value had statistically significant differences between the control and L-NAME group (P <0.05).GFRCT and GFRSPECT had obvious correlation.GFRCT of L-NAME group was obviously lower than that of the con-trol group.The kidneys of L-NAME group showed obviously injured under both light microscope and microscope.Conclusion 64-slice spiral CT functional imaging techniques can dynamically observe and quantitatively assess early hypertensive kidney dysfunc-tion,especially unilateral renal blood flow abnormalities.It is an effective examination in quantitatively assessing kidney function.
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Objective To assess the value of contrast-enhanced ultrasound (CEUS) on quantitative analysis of re?nal cortex perfusion in hypertensive rabbits model. Methods Hypertensive rabbit modal (n=10) were established by inject?ing N-nitro-L-arginin methylester (L-NAME). CEUS and Cystatin C (CysC) serum level analysis were performed at differ?ent time points:before and the 2nd, 4th, 6th and 8th week after injecting L-NAME. Time-intensity curve and area under curve (AUC) were analyzed quantatively while correlation of AUC and CysC were also analyzed. Results Serum level of Cys C in?creased significantly at the 6th week after L-NAME administration which is earlier than the increase of serum levels of Scr and BUN. AUC decreased at first then increased after L-NAME administration. Upon addition of L-NAME, rise time (RT) and peak intensity (PI) decreased while mean transit time (MTT), time from peak to one half (HPT) and time to peak (TTP) in?creased. Our study confirmed a positive correlation between AUC and Cys C (r=0.950, P<0.001). Conclusion Setting up rabbits model by L-NAME is convenient and reproducible, which is an useful tool in experimental study of preclinical and clinical phase of hypertensive renal injury. CEUS combining with CysC serum level analysis is considered as an effective technology for evaluating renal function in hypertensive patients.
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Objective To evaluate the value of multi-slice spiral computed tomography (MSCT) in diagnosing postoperative intestinal obstruction of rectal cancer.Methods The CT imaging results and clinical manifestation of 50 patients with postoperative intestinal obstruction of rectal cancer confirmed by pathology were reviewed retrospectively.These cases including Miles (24 cases),Dixon (18 cases),Hartmann(8 cases) procedure were collected from Tianjin People's Hospital from 2011 to 2013.Conservative management was done in 10 cases and the remaining 40 patient underwent surgical intervention.Statistical difference between the three kinds of surgical causes of intestinal obstruction was analysed by x2 test.Results Most common cause after Miles and Hartmann postoperative intestinal obstruction was of adhesion,while anastomotic stenosis was the most common reason of intestinal obstruction after Dixon procedure.The difference of incidence of intestinal obstruction caused by hernia and anastomotic stenosis between the three kinds of operation method was statistically significant (x2 =5.382、20.486,P < 0.05).Conclusions MSCT could identify the etiology and site of postoperative intestinal obstruction of rectal cancer,providing favorable imaging evidence for clinical treatment.