Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05025553
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2021-08-15
Brief Title:
Oral Administration of Polyethylene Glycol PEG for 6 Months in Chronically Constipated Autistic Children
Sponsor:
University of Messina
Organization:
University of Messina
Study Overview
Official Title:
Gut Mobilization With Oral Administration of Polyethylene Glycol PEG at the Dose of 69 gd Once a Day for 6 Months in Chronically Constipated Autistic Children
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many autistic children suffer from chronic constipation Gut mobilization was obtained administering polyethylene glycol PEG at the dose of 69 gd 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 69 gd 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None