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

ObjectiveWhile fecal microbiota transplantation is demonstrated to improve symptoms of autism spectrum disorder (ASD), it remains unclear whether additional treatment courses yield better results. This study sought to evaluate the efficacy of repeated washed microbiota transplantation (WMT) in children with ASD.MethodsRetrospective data from children who were serially treated with WMT, including ASD symptoms, sleep disorders, gastrointestinal (GI) symptoms, and white blood cell (WBC) and globulin levels were obtained. The effect of WMT on children with ASD and whether additional WMT courses led to a further improvement in symptoms were assessed.ResultsAberrant Behavior Checklist (ABC), Childhood Autism Rating Scale, and Sleep Disturbance Scale for Children (SDSC) scores, the proportion of children with constipation and abnormal fecal forms, and WBC and globulin levels were all significantly lower in ASD children after WMT. More WMT treatment courses led to significantly lower scores on the ABC and SDSC.ConclusionWMT significantly improved ASD and GI symptoms and sleep disorders in children with ASD, and reduced systemic inflammation. Additional WMT courses led to more obvious improvements in ASD symptoms within three treatment courses.

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“…Third, the sample size was small. Our results should be confirmed in a large, prospective, multi-center study (54).…”

Section: Discussionsupporting

confidence: 66%

Beneficial Effects of Repeated Washed Microbiota Transplantation in Children With Autism

et al. 2022

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“…Although FMT has been shown to effectively improve the symptoms of ASD, there is still no consensus on the optimal dose and treatment regimen for FMT in ASD patients ( De Angelis et al, 2015 ). Chen et al used an individualized daily intake of fecal bacteria ( Chen et al, 2022 ). Our study will use standard bacterial fluids administered in three phases: first-dose treatment, intensive treatment, and maintenance treatment.…”

Section: Discussionmentioning

confidence: 99%

Protocol for the safety and efficacy of fecal microbiota transplantation liquid in children with autism spectrum disorder: a randomized controlled study

Wei,

Chen,

Fang

et al. 2023

Front. Microbiol.

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BackgroundAutism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interaction, repetitive behavior and language impairment, and its worldwide prevalence has been found to be increasing annually in recent years. Till now, ASD is uncurable as its pathogenesis remains unknown. However, studies on both animals and humans have demonstrated that fecal microbiota transplantation (FMT) may ameliorate the symptoms of ASD, as well as gastrointestinal symptoms. Nonetheless, there is still no agreement regarding the optimal dosage or duration of FMT treatment for individuals with ASD.MethodsThis clinical study is a double-blind, randomized, interventional trial conducted at a single center. The aim is to investigate the safety and efficacy of a pediatric formulation of FMT for ASD. A total of 42 children between the ages of 3–9 with ASD will be randomly assigned in a 2:1 ratio to either an FMT treatment group (n = 28) or a placebo group (n = 14), forming cohort 1. Additionally, 30 healthy children of similar age and gender will be recruited as the control group (cohort 2). Cohort 1 will be assessed using a variety of scales, including the Autism Behavior Checklist, Childhood Autism Rating Scale, Social Responsiveness Scale, Gastrointestinal Symptom Rating Scale, Children’s Sleep Habits Questionnaire, and Psychoeducational Profile (Third Edition). These assessments will evaluate the effectiveness of FMT in reducing core symptoms and comorbidities (such as gastrointestinal symptoms and sleep disturbances) in children with ASD. The study will use metagenomic and metabolomic sequencing to assess changes in the composition and structure of the intestinal flora and its metabolites in blood, urine, and feces following treatment. Furthermore, the study will evaluate the acceptability of the FMT formulation by participants’ legal guardians and investigate differences in the intestinal flora and metabolism in the FMT group before and after treatment compared to 30 healthy children.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2200058459.

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“…69 In addition, a multicentre, doubleblind, randomised, placebo-controlled trial of FMT for ASD is ongoing in China currently. 70 The fecal and plasma metabolites of 18 children with ASD and 20 healthy children were compared. Among the 619 plasma metabolites detected in children with ASD, the levels of niacinamide nucleoside and other metabolites decreased, while the levels of octanoate and heptanoate increased.…”

Section: Effects Of Fmt On Asd Effect Of Fmt On Gastrointestinal and ...mentioning

confidence: 99%

“… 69 In addition, a multicentre, double-blind, randomised, placebo-controlled trial of FMT for ASD is ongoing in China currently. 70 …”

Section: Effects Of Fmt On Asdmentioning

confidence: 99%

Fecal Microbiota Transplantation in Autism Spectrum Disorder

Li¹,

Wang²,

Zhang³

2022

NDT

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Autism spectrum disorder (ASD) is a group of neurodevelopmental disorders that begin in infancy. In recent years, the incidence of ASD in the world is increasing year by year. At present, the etiology and pathogenesis of ASD are not clear, and effective treatments are still lacking. In addition to neurobehavioral symptoms, children with ASD often have obvious gastrointestinal symptoms. Gut microbiota is a large microbial community in the human gut, which is closely related to the nervous system and can affect brain development and behavior through the neuroendocrine, neuroimmune and autonomic nervous systems, forming a microbiota-gut-brain axis connection. Recent studies have shown that children with ASD have significant gut microbiota and metabolic disorders, and fecal microbiota transplantation (FMT) is expected to improve ASD-related symptoms by regulating gut microbiota and metabolism. This review paper will therefore focus on FMT in the treatment of ASD, and FMT is effective in improving gastrointestinal and neurobehavioral symptoms in children with ASD.

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

Cited by 8 publications

References 31 publications

Beneficial Effects of Repeated Washed Microbiota Transplantation in Children With Autism

Beneficial Effects of Repeated Washed Microbiota Transplantation in Children With Autism

Protocol for the safety and efficacy of fecal microbiota transplantation liquid in children with autism spectrum disorder: a randomized controlled study

Fecal Microbiota Transplantation in Autism Spectrum Disorder

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