Studying the effect of treating Helicobacter pylori infection on autism symptoms in children and adolescents referring to autism centers in Hamedan

Evaluating the effect of Helicobacter pylori infection treatment on autism symptoms in children and adolescents in Autism centers of Hamedan

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241211064021N8

Enrollment

Registered

2025-05-15

Start date

2025-05-24

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Studying the effect of treating Helicobacter pylori infection on autism symptoms in children and adolescents in autism centers in Hamedan. Autistic disorder

Interventions

Intervention 1: Intervention group: Recruitment of participants for the stool antigen test: The stool antigen test is performed using an ELISA kit manufactured by Pishtaz Antigen Company. If the test

Eligibility

Sex/Gender

All

Age

3 Months to 18 Years

Inclusion criteria

Inclusion criteria: Confirmation of autism spectrum disorders based on DSM-IV and CARS criteria. Informed consent from the participants' parents or legal guardians to participate in the study. Positive Helicobacter pylori stool antigen test.

Exclusion criteria

Exclusion criteria: Presence of significant motor or sensory impairments (e.g., blindness, deafness) Major physical abnormalities, seizures, or a history of serious head injury Changes in treatment process during the study for any reason.

Design outcomes

Primary

Measure	Time frame
Severity of autism symptoms: This variable is measured using the Childhood Autism Rating Scale (CARS). The primary aim of the study is to examine changes in CARS scores after Helicobacter pylori treatment. Timepoint: Before treatment: Before starting treatment for Helicobacter pylori infection, the above variable is measured in all participants. After treatment: Changes are assessed at specified time intervals (e.g., after 2 weeks, 4 weeks, 8 weeks, and 12 weeks from the start of treatment). Long-term follow-up: To assess the stability of improvement, measurements are also performed at longer time intervals (e.g., 3 months, 6 months, and 1 year after treatment). Method of measurement: This variable is measured using the Childhood Autism Rating Scale (CARS).	—

Measure

Time frame

Severity of autism symptoms: This variable is measured using the Childhood Autism Rating Scale (CARS). The primary aim of the study is to examine changes in CARS scores after Helicobacter pylori treatment. Timepoint: Before treatment: Before starting treatment for Helicobacter pylori infection, the above variable is measured in all participants. After treatment: Changes are assessed at specified time intervals (e.g., after 2 weeks, 4 weeks, 8 weeks, and 12 weeks from the start of treatment). Long-term follow-up: To assess the stability of improvement, measurements are also performed at longer time intervals (e.g., 3 months, 6 months, and 1 year after treatment). Method of measurement: This variable is measured using the Childhood Autism Rating Scale (CARS).

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Secondary

Measure	Time frame
Improving public health. Timepoint: Before treatment: Before starting treatment for Helicobacter pylori infection, the above variable is measured in all participants. After treatment: Changes are assessed at specified time intervals (e.g., after 2 weeks, 4 weeks, 8 weeks, and 12 weeks from the start of treatment). Long-term follow-up: To assess the stability of improvement, measurements are also performed at longer time intervals (e.g., 3 months, 6 months, and 1 year after treatment). Method of measurement: Physical evaluation by a doctor: Regular physical examinations are performed to track changes in general health status, especially regarding digestive symptoms.	—

Measure

Time frame

Improving public health. Timepoint: Before treatment: Before starting treatment for Helicobacter pylori infection, the above variable is measured in all participants. After treatment: Changes are assessed at specified time intervals (e.g., after 2 weeks, 4 weeks, 8 weeks, and 12 weeks from the start of treatment). Long-term follow-up: To assess the stability of improvement, measurements are also performed at longer time intervals (e.g., 3 months, 6 months, and 1 year after treatment). Method of measurement: Physical evaluation by a doctor: Regular physical examinations are performed to track changes in general health status, especially regarding digestive symptoms.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMobina Mohammad Rezaei

Hamedan University of Medical Sciences

Hbazmamoun@yahoo.com+98 81 3131 0000

Outcome results

None listed

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