Constipation Clinical Trial
Official 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.
Verified date | August 2021 |
Source | University of Messina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | February 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 8 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Interdipartimental Program "Autismo 0-90" at "G. Martino" University Hospital | Messina | ME |
Lead Sponsor | Collaborator |
---|---|
University of Messina |
Italy,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in stool quality | 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"). | At baseline (T0) prior to gut mobilization; 1 month (T1) and 6 months (T2) after gut mobilization | |
Primary | Change from baseline urinary concentrations of total p-cresol | 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. | First-morning urines were collected at home by parents at baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization | |
Primary | Change in Childhood Autism Rating Scale (CARS) | 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 | At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization | |
Primary | Change in Repetitive Behavior Scale-Revised (RBS-R) | 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). | At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization | |
Primary | Change in Conners' Parent Rating Scale - Revised (CPRS-R) | 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). | At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization | |
Primary | Change in Social Responsiveness Scale (SRS) | 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). | At baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization |
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