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?CLINICAL STUDIES ON THE EFFECTIVENESS OF THE GLUTEN-FREE DIET AND CASEIN AND THERAPY ANTI-INFLAMMATORY BOWEL CHANGE IN PSYCHIATRIC SYMPTOMS INTESTINAL AND IN PATIENTS WITH CHILDHOOD AUTISMO? - ND

?CLINICAL STUDIES ON THE EFFECTIVENESS OF THE GLUTEN-FREE DIET AND CASEIN AND THERAPY ANTI-INFLAMMATORY BOWEL CHANGE IN PSYCHIATRIC SYMPTOMS INTESTINAL AND IN PATIENTS WITH CHILDHOOD AUTISMO? - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012102-39-IT
Enrollment
Unknown
Registered
2009-07-03
Start date
2009-07-03
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

patients with autism and gastrointestinal symptoms

Interventions

Pharmaceutical Form: Gastro-resistant capsule, soft INN or Proposed INN: Aminosalicylic acid and similar agents Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800

Sponsors

AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: autistic disorder diagnosed according to criteria DSM IV-TR (ICD10 Typical Autism F84.0), aged between 3 and 18 years. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Will be excluded subjects with serious pathological conditions associated, patients who have a autism secondary to other neuropsychiatric disorder, their brain syndrome is malformed. Mental retardation and epilessia not a criterion for exclusion.

Design outcomes

Primary

MeasureTime frame
Main Objective: Ascertain the extent of intestinal-colitis autistic symptoms in patients for gastrointestinal disorders.;Secondary Objective: To evaluate the changes of the clinical neuro-psychiatric and inflammatory bowel disease with the introduction of the diet devoid of gluten and casein in patients with autistic intestinal-colitis. To evaluate the changes of the clinical neuro-psychiatric and inflammatory bowel disease with the introduction of pharmacological treatment in patients with autistic intestinal-colitis.;Primary end point(s): Ratings nervous (use of scale CARS-Childhood Autism Rating Scale Schopler et al 1998 - and wide-ECA R-Echelle d`e`valuation des comportements Autistiques The lord et al 1997) will be conducted for the evaluation of the effectiveness of therapy on the clinical picture before treatment and after 6 months to 12 months and at the end of the study after 2 years.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026