Autism Spectrum DisorderNCT06662916
Gut Microbiota Diversity: Wrong Message in Autism, Wrong Architecture in Formation
An observational study of Autism Spectrum Disorder and Gut -Microbiota, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Gut -Microbiota, Neurodevelopment Outcome
- What is being tested?
- Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 320 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Having a genetic syndrome (such as Rett, Angelman syndrome)
- Having an additional chronic disease
- Following a different diet program other than our center
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basakşehir Cam & Sakura City Hospital, Autism Nutrition and Research Center
Istanbul, Basaksehir, 34480
About this study
Official title: 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.
Read the 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.
- Being tested
- Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Microbiota Diversity, Diet, Neurodevelopment outcome
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota-Diversity Enhancing Diet on children with Autism Spectrum DisorderBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of 12-month time period
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of 12-month time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jan 2017
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Onal, MD, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662916
- Sponsor's protocol ID
- SBUCAMSAKURAEAH
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Topuz HS, Kurnaz ME, Keles ES, Ersen A, Onal H. Effect of a Novel Mediterranean-Style Diet (MIND-DASE) on Behavioural and Developmental Outcomes in Children With Autism Spectrum Disorder: A Propensity Score-Matched Analysis. J Paediatr Child Health. 2026 Sep 29. doi: 10.1111/jpc.70606. Online ahead of print.
PubMed 42808189
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota-Diversity Enhancing Diet on Children With Autism Spectrum Disorder: The MIND-DASE Study
- ClinicalTrials.gov ID
- NCT06662916
- Acronym / sponsor ID
- SBUCAMSAKURAEAH
- Keywords
- Autism Spectrum Disorder, Microbiota Diversity, Diet, Neurodevelopment outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 220 ASD cases regularly followed our specific diet | – | Behavioral: Microbiota-Diversity Enhancing Diet on children with Autism Spectrum Disorder220 individuals who regularly followed our specific diet program for at least 12 months were identified as a study group. |
| 100 ASD cases who did not have diet compliance | – | –100 children with ASD who did not have diet compliance were identified as control group. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Having a genetic syndrome (such as Rett, Angelman syndrome)
- Having an additional chronic disease
- Following a different diet program other than our center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota-Diversity Enhancing Diet on children with Autism Spectrum DisorderMicrobiota-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 | Behavioural | 220 ASD cases regularly followed our specific diet |
Primary outcome
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.
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.
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.
2 secondary outcomes
Height status in diet and non-diet group
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 42808189Topuz HS, Kurnaz ME, Keles ES, Ersen A, Onal H. Effect of a Novel Mediterranean-Style Diet (MIND-DASE) on Behavioural and Developmental Outcomes in Children With Autism Spectrum Disorder: A Propensity Score-Matched Analysis. J Paediatr Child Health. 2026 Sep 29. doi: 10.1111/jpc.70606. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Gut -Microbiota, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.