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Completed

NCT Number: NCT05025553

Oral Administration of Polyethylene Glycol (PEG) for 6 Months in Chronically Constipated Autistic Children

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.

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Key information

Conditions

Autistic Spectrum Disorder Anxiety Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Constipation Mental Disorders Neurodevelopmental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interdipartimental Program "Autismo 0-90" at "G. Martino" University Hospital

Messina, ME, I-98125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • ASD constipated children already treated with laxatives

Treatment and study plan

Gut mobilization

Dietary Supplement

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.

Primary outcomes

  1. Change in stool quality

    Time frame: 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").

  2. Change from baseline urinary concentrations of total p-cresol

    Time frame: 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.

  3. Change in Childhood Autism Rating Scale (CARS)

    Time frame: 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

  4. Change in Repetitive Behavior Scale-Revised (RBS-R)

    Time frame: 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).

  5. Change in Conners' Parent Rating Scale - Revised (CPRS-R)

    Time frame: 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).

  6. Change in Social Responsiveness Scale (SRS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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