se of Gastrin-Releasing Peptide in Children with Autism Diagnosis

Not Applicable

• Conditions: Childhood autism; F84.0

• Registration Number: RBR-8cq282
• Lead Sponsor: Programa de Pós-Graduação em Saúde da Criança e Adolescente - Universidade Federal do Rio Grande do Sul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Autism Diagnostic according to DSM-5 criteria, as confirmed by the investigator's judgment; Age between 3 and 9 years; Normal Neuroimaging (computed tomography or magnetic resonance imaging of the skull); Normal Genetic research (karyotype for girls; karyotyping and Fragile X research for boys); Subjects of use of psychopharmacological treatment considered appropriate by the investigator on a stable dose for at least 4 weeks before inclusion, without adjustment of the dose throughout the study;

Exclusion Criteria

History of diabetes mellitus; Secondary autism presence or diseases with features common to autism, as follows: diagnosis of fragile X syndrome, Rett syndrome, Angelman syndrome, Prader-Willi syndrome and Smith-Lemli-Opitz syndrome, Tuberous Sclerosis; Be carrier of any condition associated with increased acid secretion in the gastrointestinal system (gastritis, gastric ulcer, duodenal ulcer, reflux esophagitis); History of heart disease; Any guy whose basic medication require dose adjustment or interruption; Any condition that, in the opinion of the investigator, would put the security of the individual at risk after exposure to the test substance; Reside outside the city of Porto Alegre and the metropolitan area; Parents or guardians refuse to sign the free and informed consent.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the characteristic symptoms of autism evaluated across the scale Aberrant Behavior Checklist (ABC)and your subscales Irritability; Lethargy and Social Withdrawal; Stereotyped behavior; Hyperactivity and Noncompliance and Inappropriate Speech with statistically significant difference (P <0.05) between the values after the use of GRP and placebo.<br>;There was a reduction in scale scores ABC and its subscales after the use of GRP and placebo. Despite this reduction be more prominent with the GRP, particularly in subscales Irritability, Stereotyped behavior and Hyperactivity, there was no statistical difference between the results (p 0.334). After a week of infusion, 5 children had improved more than 25% in the total score of the ABC scale use of GRP and 2 with placebo use, not being statistical difference (p 0.375).

Secondary Outcome Measures

Name	Time	Method
Assess possible placebo effect, tolerance GRP infusions and possible adverse effects through monitoring of vital signs during infusions and clinical reassessment in applications ABC scale.;;No adverse effects, changes in vital signs or laboratory abnormalities associated with use of GRP or placebo in any patient.