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

October 26, 2024 updated by: Hasan Onal, MD, Kanuni Sultan Suleyman Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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.
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.
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.
From enrollment to the end of 12-month time period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of 12-month time period
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.
From enrollment to the end of 12-month time period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of 12-month time period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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