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

NCT06662916 | Completed DMC

• 1 other identifier: SBUCAMSAKURAEAH
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Gut -Microbiota; Neurodevelopment Outcome

Keywords

Autism Spectrum Disorder; Microbiota Diversity; Diet; Neurodevelopment outcome

Outcome Measures

Primary Outcomes (3)

• Changes in ATEC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.

  ATEC scores will be evaluated by a specialist psychiatric nurse in both groups. ATEC is a parent-completed questionnaire and has four subscales. A total score, which ranges from 0-179 points, is calculated from combined scores of each subscale. A lower ATEC score indicates improvement of ASD symptoms and a higher score correlates with more severe symptoms.

  From enrollment to the end of 12-month time period

• Changes in ABC scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.

  ABC scores will be evaluated by a specialist psychiatric nurse in both groups. ABC is a scale for determining the behavioral problems in ASD children. It consists of 5 subscales and 58 items. Each item is rated on a four-point scale ranging from 0 (not a problem) to 3 (the problem is severe). Evaluation is based on the scores obtained from the subscales; minimum 0 points to maximum 174 points.

  From enrollment to the end of 12-month time period

• Changes QoLA-P scores in diet (study) and non-diet (control) ASD participants from baseline to 1 year period.

  The QoLA-P scores will be evaluated by a specialist psychiatric nurse in both groups. QoLA-P is designed as two subscales: Section A evaluates parent's perceptions about their own QoL, and section B measures the perceptions of parent's problems lived with an autistic child. Total score from this questionnaire ranges from 48 to 240 and higher scores show lesser severity effect.

  From enrollment to the end of 12-month time period

Secondary Outcomes (2)

• Height status in diet and non-diet group

  From enrollment to the end of 12-month time period

• Weight status in diet and non-diet group

  From enrollment to the end of 12-month time period

Other Outcomes (1)

• Observation of eating pattern

  From enrollment to the end of 12-month time period

Study Arms (2)

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.

Behavioral: Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder

100 ASD cases who did not have diet compliance

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

Interventions

Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder 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

220 ASD cases regularly followed our specific diet

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof M.D.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 29, 2024
• Study Start: January 1, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)