Clinical Trials Logo

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


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

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
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 NCT02658201 - Ultrafast MRI Imaging to Exclude Constipation N/A
Completed NCT01695915 - Diurnal Variation in Rectal Diameter N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Completed NCT02863848 - Effect of Inulin-type Fructans on Constipated Children. N/A
Completed NCT01411501 - Efficacy and Safety of Acupuncture for Functional 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 NCT01474499 - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation 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
Terminated NCT01003249 - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen Phase 4
Completed NCT00994851 - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment. Phase 3