Gut Microbiota Diversity: Wrong Message in Autism, Wrong Architecture in Formation

NCT ID: NCT06662916

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2022-12-30

Brief Summary

Our dietary diversity has changed day by day in industrial age. A low dietary diversity may alter gut microbiota diversity and functional capacity. Wrong messages sourced from gut microbiota were speculated to have a bad influence on autism spectrum disorder (ASD) severity. A new nutritional model aiming to increase microbiota diversity in children with ASD can improve social and communicative behaviors in these children. The investigators compared 220 ASD patients who regularly followed a specific diet program for at least 12 months with randomly selected 100 children with ASD who did not have diet compliance in terms of nutritional status and regular behavioral assessments with special scales (ATEC, ABC, QoLA-P scales). The investigators arised a question that the Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) which is a specific dietary intervention may have benefits on the neurodevelopmental outcomes of children with ASD.

Detailed Description

Since industrialization has altered human diet models, we faced with a low dietary diversity, reduced gut microbiota diversity and functional capacity day by day. These changes in gut microbiota have been speculated to associate with severity of autism spectrum disorder (ASD). The investigators researched the possible therapeutic effects of a new nutritional model aiming to increase microbiota diversity in children with ASD. Question is: Can we improve social and communicative behaviors in children with ASD by increasing microbiota diversity through a specific diet? A total of 2000 children diagnosed with ASD and followed in Autism Nutrition Research Center in investigators' hospital were screened: a) a total of 220 participants aged between 2-18 years who regularly followed the specific diet program for at least 12 months were identified as a study group, and b) randomly selected 100 children with ASD who did not have diet compliance were identified as control group. Assessments included dietary adherence and behavioral evaluations using baseline, 6th and 12th month Autism Treatment and Evaluation Checklist (ATEC), Aberrant Behavior Checklist (ABC), The Quality of Life in Autism Questionnaire- Parent version (QoLA-P) scales. The investigators compared diet and non-diet groups by evaluating demographic data, clinical symptoms, diet compliance status and ATEC, ABC, and QoLA-P scores in 12-month time period. The investigators foced on The Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) which is a specific dietary intervention may have significant benefits on the neurodevelopmental outcomes of children with ASD.

Conditions

Autism Spectrum Disorder; Gut -Microbiota; Neurodevelopment Outcome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

220 ASD cases regularly followed our specific diet

220 individuals who regularly followed our specific diet program for at least 12 months were identified as a study group.

Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder

Intervention Type: BEHAVIORAL

Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) suggested that increasing microbiota diversity through dietary interventions can have significant benefits on the neurodevelopmental outcomes of children with ASD

100 ASD cases who did not have diet compliance

100 children with ASD who did not have diet compliance were identified as control group.

No interventions assigned to this group

Interventions

Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder

Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) suggested that increasing microbiota diversity through dietary interventions can have significant benefits on the neurodevelopmental outcomes of children with ASD

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals who were diagnosed ASD by a pediatric psychiatrist or a pediatric neurologist according to the DSM-V criteria
• Having continued follow-up in our center at least 12 months regularly
• Being between the ages of 2-18

Exclusion Criteria

• Having a genetic syndrome (such as Rett, Angelman syndrome)
• Having an additional chronic disease
• Following a different diet program other than our center

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hasan Onal, MD

Prof M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Basakşehir Cam & Sakura City Hospital, Autism Nutrition and Research Center

Istanbul, Basaksehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBUCAMSAKURAEAH

Identifier Type: -

Identifier Source: org_study_id