Oral Administration of Polyethylene Glycol (PEG) for 6 Months in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05025553
Study type	Interventional
Source	University of Messina
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2018
Completion date	February 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Recruiting	`NCT06292949` - Clinical Study of Resistant Starch in Improving Constipation	N/A
Recruiting	`NCT04132661` - MRI Assessment of Mode of Action of Bisacodyl, Single Dose	Phase 4
Recruiting	`NCT05734833` - Do Probiotics Improve Recovery From Acute Constipation in Kids?	N/A
Completed	`NCT02726295` - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study	Phase 4
Terminated	`NCT02839889` - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)	Phase 4
Recruiting	`NCT02255747` - Anal Dilatation for Infants and Children With Constipation	N/A
Completed	`NCT02246647` - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed	`NCT01566409` - Maintenance Treatment for Children With Constipation	N/A
Completed	`NCT02863848` - Effect of Inulin-type Fructans on Constipated Children.	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Completed	`NCT02658201` - Ultrafast MRI Imaging to Exclude Constipation	N/A
Completed	`NCT01695915` - Diurnal Variation in Rectal Diameter	N/A
Completed	`NCT01411501` - Efficacy and Safety of Acupuncture for Functional Constipation	Phase 3
Completed	`NCT01474499` - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation	Phase 3
Completed	`NCT01438567` - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy	Phase 3
Completed	`NCT01170039` - The Effectiveness of Lubiprostone in Constipated Diabetics	Phase 4
Completed	`NCT00931853` - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).	Phase 3
Active, not recruiting	`NCT02442115` - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed	`NCT00994851` - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms