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Completed

NCT Number: NCT06662916

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Gut -Microbiota Mental Disorders Neurodevelopment Outcome Neurodevelopmental Disorders

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: From enrollment to the end of 12-month time 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.

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

    Time frame: From enrollment to the end of 12-month time 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.

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

    Time frame: From enrollment to the end of 12-month time 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.

Secondary outcomes

  1. Height status in diet and non-diet group

    Time frame: From enrollment to the end of 12-month time period

    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.

  2. Weight status in diet and non-diet group

    Time frame: From enrollment to the end of 12-month time period

    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.

Other outcomes

  1. Observation of eating pattern

    Time frame: From enrollment to the end of 12-month time period

    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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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