Clinical trial NCT06662916: Gut Microbiota Diversity: Wrong Message in Autism, Wrong Architecture in Formation
Official title: Microbiota-Diversity Enhancing Diet on Children With Autism Spectrum Disorder: The MIND-DASE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Gut -Microbiota
Neurodevelopment Outcome
Keywords: Autism Spectrum Disorder
Microbiota Diversity
Diet
Neurodevelopment outcome
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 320
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

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.

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

Primary outcomes:
measure: Changes in ATEC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
timeFrame: From enrollment to the end of 12-month time period
measure: Changes in ABC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
timeFrame: From enrollment to the end of 12-month time period
measure: Changes QoLA-P scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.
timeFrame: From enrollment to the end of 12-month time period
Secondary outcomes:
measure: Height status in diet and non-diet group
timeFrame: From enrollment to the end of 12-month time period
measure: Weight status in diet and non-diet group
timeFrame: From enrollment to the end of 12-month time period
Other outcomes:
measure: Observation of eating pattern
timeFrame: From enrollment to the end of 12-month time period
Locations:
city: Istanbul
country: Turkey
facility: Basakşehir Cam & Sakura City Hospital, Autism Nutrition and Research Center
state: Basaksehir
Study officials:
References: