Oral Administration of Polyethylene Glycol (PEG) for 6 Months in Chronically Constipated Autistic Children
Condition: Autistic Spectrum Disorder; Constipation
MeSH terms: Constipation; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Gut mobilization
Intervention type(s): Dietary Supplement
Intervention description(s): Polyethylene Glycol (PEG) at the Dose of 6.9 g/d Once a Day for 6 Month. Children were observed and tested at baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization.
Intervention model: Single Group Assignment
Intervention model description: In this open trial, each child underwent gut mobilization using a standard protocol with oral administration of PEG (6.9 g/d once a day) for 6 months. Children were observed and behaviorally tested at baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization.
At the time of recruitment, Intellectual Quotient (IQ) or Developmental Quotient (DQ) were determined using the Leiter International Performance Scale-Third Edition or the Griffith Mental Development Scales, respectively. Autistic behaviors were assessed using the ADOS-2, and the Children Autism Rating Scales (CARS). Adaptive functioning was assessed using the Vineland Adaptive Behavior Scales-Second Edition
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; 4-cresol; anxiety; autism spectrum disorder; biomarkers; constipation; microbiota