Gut Mobilization With Oral Administration of Polyethylene Glycol (PEG) at the Dose of 6.9 g/d Once a Day for 6 Months in Chronically Constipated Autistic Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in stool quality
研究概览
简要总结
Many autistic children suffer from chronic constipation. Gut mobilization was obtained administering polyethylene glycol (PEG) at the dose of 6.9 g/d once a day for 6 months in an open trial involving 21 chronically constipated autistic children 2-8 years old, followed prospectively for 6 months. Children diagnosed with Autism Spectrum Disorder by DSM-5 and confirmed by ADOS-2 criteria, were evaluated before (T0), 1 month (T1), and 6 months (T2) after intestinal mobilization, recording Bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity.
详细描述
Chronic constipation is common among children with ASD and is associated with more severe anxiety, hyperactivity, irritability and repetitive behaviors. Young autistic children with chronic constipation display higher urinary and foecal concentrations of p-cresol, an aromatic compound produced by gut bacteria, known to negatively affect brain function. Acute p-cresol administration to BTBR mice enhances anxiety, hyperactivity and stereotypic behaviors, while blunting social interaction. This study was undertaken to prospectively assess the behavioral effects of gut mobilization in young autistic children with chronic constipation, and to verify their correlation with urinary p-cresol. To this aim, 21 chronically constipated autistic children 2-8 years old were evaluated before (T0), 1 month (T1), and 6 months (T2) after intestinal mobilization, recording Bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity. Gut mobilization was obtained administering PEG (6.9 g/d once a day) for 6 months. A progressive, statistically significant decrease in all behavioral symptoms was recorded over the six-month study period. Urinary p-cresol levels displayed variable trends, mainly increasing at T1 and decreasing at T2. These results support gut mobilization as a simple strategy to at least partly ameliorate ASD symptoms, as well as comorbid anxiety and hyperactivity, in chronically constipated children. These beneficial effects likely involve multiple mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling DSM-5 diagnostic criteria for Autism Spectrum Disorder
- •Chronic constipation, namely unsatisfactory defecation characterized by difficult and infrequent passage of lumpy and hard stools during at least the previous 3 months, as reported by parents based on the Bristol Stool Scale
排除标准
- •ASD constipated children already treated with laxatives
结局指标
主要结局
Change in stool quality
时间窗: At baseline (T0) prior to gut mobilization; 1 month (T1) and 6 months (T2) after gut mobilization
Stool quality was assessed by parental report using the Bristol Stool Scale (score ranges from 1 to 7, where 1 is "lumpy constipation" and 7 is "liquid diarrhoea").
Change in Conners' Parent Rating Scale - Revised (CPRS-R)
时间窗: At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization
48-item rating scale used to evaluate through parental reports the presence of childhood hyperactivity/inattention, impulsivity and externalizing behaviors (scores for each item range from 0="not true, never, rarely" to 4="very true, very often or very frequent"; diagnostic threshold score = 60).
Change from baseline urinary concentrations of total p-cresol
时间窗: First-morning urines were collected at home by parents at baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization
Urinary concentrations of total p-cresol, encompassing on average 95% p-cresylsulfate, 3%-4% p-cresylglucuronide and 0.5%-1% of unconjugated free p-cresol, were measured by HPLC three times, averaged and normalized by urinary specific gravity.
Change in Repetitive Behavior Scale-Revised (RBS-R)
时间窗: At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization
44- item questionnaire used to assess repetitive behaviors. Scores range from 0 to 3 (0 = the behavior does not occur, 3 = the behavior is present and severe). Overall rating (last question) ranges from 0 to 100, indicating that the set of behaviors described in the questionnaire do not represent a problem at all (0) or instead represent an extremely severe problem (100).
Change in Childhood Autism Rating Scale (CARS)
时间窗: At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization
The Childhood Autism Rating Scale is a clinical rating scale for the trained clinician to rate the presence and severity of signs and symptoms of ASD by direct observation of the child. Scores can range from 15 to 60: below 30, non autistic; 30-36.5 mild to moderate autism; 37-60, severe autism
Change in Social Responsiveness Scale (SRS)
时间窗: At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization
65-item questionnaire used to assess social impairment, communication deficits and repetitive behaviors (T scores: \<60, normal range; 60-65, mild deficits; 66-75, moderate deficits; 76 or above, severe deficits in reciprocal social behavior).
次要结局
未报告次要终点
研究者
Antonio Persico
Full Professor in Child & Adolescent Neuropsychiatry
University of Messina