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Study with use of gastrin releasing peptide in children with autism

Experimental Study of a Case Series of Gastrin-releasing Peptide use in Pediatric Patients with Autism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2cctcn
Enrollment
Unknown
Registered
2015-08-17
Start date
2012-03-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum disorders

Interventions

Administration releasing peptide gastrin (GRP) 10 participants, intravenously, at a dose of 160 picomol / kg, continuous infusion of 30 minutes duration, 1x daily for 4 consecutive days. GRP study was
Other
DeCS 33423

Sponsors

Fundo de Investimento a Pesquisa e a Eventos do Hospital de Clínicas de porto Alegre
Lead Sponsor
Fundação Sul-Americana para o Desenvolvimento de Drogas Anti-Câncer
Collaborator

Eligibility

Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: Diagnosis of infantile autism by the criteria of the Diagnostic and Statistical Manual of Mental Disorders, aged between 3 and 18; CT scan or MRI of normal brain; karyotype and normal research Fragile X;

Exclusion criteria

Exclusion criteria: Conditions associated with an increased acid secretion in the gastrointestinal tract such as gastritis, gastric ulcer, duodenal ulcer, reflux esophagitis; diabetes; heart disease; residence outside of Porto Alegre and the metropolitan area; secondary autism to genetic disorders or sensory deficits;

Design outcomes

Primary

MeasureTime frame
Reduction or improvement in symptoms of autistic spectrum disorder, seen through the instruments Clinical Global Improvement Scale-Impressionas (CGI-I), Aberrant Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS) and Autism Diagnostic Interview- Revised (ADI-R). Improvement was defined as a score of 1 (very much better) or 2 (better) in the CGI-I and a decrease of 25% or more scores in at least one of the subscales of ABC.;Results: Six (60%) of the 10 participants showed improvement after GRP. The subscales of the ABC analysis showed that 8 patients (80%) showed improvement in subscales Irritability and Hyperactivity, 7 in subscales Stereotyped behaviors and Lethargy and social withdrawal (70%) and 4 subscale Inappropriate Speaks (40%). The larger effect sizes were the Irritability subscale (1.72) and Lethargy and social withdrawal (1.57) .In CARS there was an average reduction of 4 points after administration of GRP (4.3 ± 2.9; p = 0.001), with an effect size of 1.4. Analysis of the ADI-R results showed significant improvement in the field that assesses social interaction, with an average reduction of 2.4 points (2.4 ± 2.83; p = 0.025). The effect size in this field was 0.85.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactGilberto Schwartsmann

Universidade Federal do Rio Grande do Sul

gilberto.ez@terra.com.br+55 (51) 3359 8012

Outcome results

None listed

Source: REBEC (via WHO ICTRP)