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

Microbiota-Diversity Enhancing Diet on Children With Autism Spectrum Disorder: The MIND-DASE Study

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Gut -Microbiota; Neurodevelopment Outcome
• Intervention / Treatment: Behavioral: Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder

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.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• Turkey
  • Basaksehir
    • Istanbul, Basaksehir, Turkey, 34480
      • Basakşehir Cam & Sakura City Hospital, Autism Nutrition and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height status in diet and non-diet group	Participants' height (cm) values will be recorded at baseline and 3-month intervals. These values will be compared in between the groups during the time period.	From enrollment to the end of 12-month time period
Weight status in diet and non-diet group	Participants' weight (kg) values will be recorded at baseline and 3-month intervals. These values will be compared in between the groups during the time period.	From enrollment to the end of 12-month time period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observation of eating pattern	A selective eating pattern such as food rejection, food selectivity, excessive and persistent consumption of selected food will be recorded in the participants. The rate of diet compliance will be determined in ASD patients. We will observe whether these families have difficulty in adapting to the diet.	From enrollment to the end of 12-month time period

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 26, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Diet; Autism Spectrum Disorder; Microbiota Diversity; Neurodevelopment outcome
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: SBUCAMSAKURAEAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No