Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Modulation of Gastrointestinal Symptoms in ASD with Postbiotic Supplement
研究概览
简要总结
Recent research links gut microbiota alterations to Autism Spectrum Disorders (ASD), a neurobiological condition with multifactorial bases. In some ASD patients, altered gut flora and increased intestinal permeability are observed, influencing the central nervous system's development and function. Chronic gastrointestinal (GI) symptoms are commonly associated with ASD and correlate with its severity. This non-pharmacological interventional clinical study aims to investigate the role of gut microbiota on ASD and the effectiveness of postbiotic-based dietary supplements in children aged 3-8 years old. Gastrointestinal symptoms, behavioral profile and analysis of intestinal metagenomic and metabolomic profiles will be assessed before and after one-month treatment. The results of the study could enhance understanding of non-pharmacological therapeutic approaches in ASD and improve clinical management strategies and the behavioural functioning for children with ASD.
详细描述
Modulating the microbiota could be an effective way to improve gastrointestinal issues and related behavioral symptoms in children with ASD, offering new treatment avenues. There is particular interest in alternatives to fecal microbiota transplantation, such as postbiotic supplements, which contain molecules naturally released during microbiota metabolism.
These molecules can regulate intestinal homeostasis and microbe-host interactions generating health benefits, possess anti-inflammatory and immunomodulatory activities, and contribute to the barrier activity of the intestinal epithelium. In line with findings for other nutraceutical therapies, dietary supplementation with postbiotics could resolve bowel problems in children with ASD and have positive consequences on behavioral regulation; however, the data collected in the literature is still scarce and limited to studies on mouse models of ASD.
This non-pharmacological clinical study, part of a collaboration between Fondazione IRCCS Istituto Neurologico Carlo Besta (FINCB) and Istituto Clinico Humanitas (ICH), evaluates postbiotic-based supplements' impact on gut microbiota's role in ASD.
Stool samples will be collected from patients at FINCB and FDG, and transported to ICH for analysis of the intestinal bacterial community and intestinal permeability. Participants will then receive a postbiotic-based dietary supplement. After treatment, changes in bowel habits, intestinal bacteria characteristics, intestinal permeability, and any behavioral changes will be evaluated.
Existing literature highlights the protective effects of postbiotics derived from Lactobacillus paracasei CNCM I-5220 on the intestine, specifically contributing to the maintenance of intestinal barrier integrity and protection against leaky gut syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 and 2:
- •Inclusion criteria
- •Diagnosis of ASD according to DSM-5 diagnostic criteria;
- •Clinical neurological evaluation by child neurologist and neuropsychologist with administration of standardized instruments such as Autism Diagnostic Observation Schedule-2 (ADOS-2) and/or Autism Diagnostic Interview-Revised (ADI-R) to support diagnosis;
- •Assessment of psychomotor or intellectual development (Griffiths Scales, Wechsler Scales, Leiter Scale)
- •Assessment of the following symptoms in the past three months: constipation, diarrhea, abnormal stool consistency, abnormal stool smell, flatulence, abdominal pain, unexplained daytime irritability, and nighttime awakening, and abdominal tenderness. The degree of gastrointestinal disturbances will be quantified before recruitment using an Italian version of the GI Severity Index. A score of at least 2 in a single item of gastrointestinal symptoms (item 1-6) was required for entry into the symptomatic group.
- •Signed informed consent for analysis of intestinal microbiota and metabolome and administration of nutraceutical therapy with PostbiotiX Comfort ®.
- •Group 3 Inclusion criteria
- •Males or females aged between 3 and 8 years whit typical development and absence of gastrointestinal symtomps
- •Signed informed consent for analysis of intestinal microbiota and metabolome
排除标准
- •Group 1 and 2
- •Exclusion Criteria
- •Children with syndromic ASD or defined genetic diseases;
- •Subjects with significant health problems requiring surgical treatment or continuous medical; treatment;
- •Severe gastrointestinal problems requiring immediate (life-threatening) treatment;
- •Severely underweight/malnourished children;
- •Use of medications that may affect biomarkers assessed, for example: antibiotics and/or pre-, probiotics within 1 month prior to enrollment.
- •Group 3 exclusion criteria
- •- Participants with gastrointestinal problems requiring immediate (life-threatening) treatment, or with gastrointestinal symptoms such as chronic irregular bowel movements (constipation, diarrhea), encopresis, recurrent abdominal bloating and pain, gastroesophageal reflux and vomiting, or food aversion.
研究组 & 干预措施
Group 1 (ASD with gastrointestinal symptoms):
30 patients with Autism Spectrum Disorder and coexisting gastrointestinal disorders, aged 3 to 8 years (male or female)
干预措施: PostbiotiX Comfort® (Dietary Supplement)
Group 2 (ASD without gastrointestinal symptoms)
30 participants with Autism Spectrum Disorder without gastrointestinal disorders, aged 3 to 8 years (male or female)
干预措施: PostbiotiX Comfort® (Dietary Supplement)
Group 3 (Typically developing)
30 participants with typical neurodevelopment and no gastrointestinal symptoms, aged 3 to 8 years (male or female)
干预措施: Control (Other)
结局指标
主要结局
Modulation of Gastrointestinal Symptoms in ASD with Postbiotic Supplement
时间窗: 24 months
The presence of gastrointestinal symptoms will be assessed at recruitment (T0) using the GI Severity Index. Subjects recruited will be treated with the postbiotic-based dietary supplement, PostbiotiX Comfort®, once daily for 1 month. The GI Severity Index will be repeated within one week after the end of the treatment (T1) to quantify changes in bowel regulation and one month after the end of the treatment (T2) to assess the stability of the observed changes.
次要结局
- Effects of postbiotics on sleep regulation(24 months)
- Effects of postbiotics on behavioral regulation(24 months)
- Effects of postbiotics on sensory profile(24 months)
- Metagenomic analyses in typically developing children and in ASD before and after postbiotic treatment(24 months)
- Metabolomic analyses in typically developing children and in ASD before and after postbiotic treatment(24 months)
- Intestinal permeability analyses in typically developing children and in ASD before and after postbiotic treatment(24 months)
- Investigation of the relationships between metagenomic/metabolomic profiles and behavioral/GI outcomes in children with ASD(24 months)