Autism Spectrum DisorderNCT06852027
Different Dietary Practices in Children with Autism Spectrum Disorder
A study testing Different Dietary Practices in people with Autism Spectrum Disorder, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of gluten-free casein-free diet and feingold diet on gastrointestinal system (GI) symptoms , eating behavior and quality of life in children with autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Different Dietary Practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:Children with autism between the ages of 3-10 registered at Efeler Autism Life Center in Aydın province.
The criteria for inclusion for the gluten-free-casein-free diet are as follows:
- Not having diseases such as celiac, lactose intolerance
- Not having previously applied a gluten-free diet, gluten-free casein-free diet, lactose-free diet
- Having gastrointestinal complaints
The criteria for inclusion for the Feingold Diet are as follows:
- Not having been diagnosed with attention deficit and hyperactivity disorder
- Not having previously taken the Feingold diet
- Not having any food allergies
Exclusion Criteria:People who do not comply with the diet or do not respond to the survey will be excluded from the study and the information obtained will not be used for the research.
- The patient is breastfed
- The patient has any chronic disease
- The patient has any psychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Aydin province Efeler Autism Life Center
Aydin
About this study
Official title: Evaluation of the Effects of Different Dietary Practices on Quality of Life and Eating Behavior in Children with Autism Spectrum Disorder
The aim of this study is to investigate the effects of gluten-free casein-free diet and feingold diet on gastrointestinal system (GI) symptoms , eating behavior and quality of life in children with autism spectrum disorder. Research questions are below:
Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on GI symptoms? Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on eating behavior? Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on quality of life?
Read the detailed description
Autism Spectrum Disorder is defined as different neurodevelopmental disorders characterized by social communication, restrictive, repetitive, and typical behaviors and interests. Although it is not known precisely how the disease develops, literature reviews see genetic and environmental factors as the leading causes. The prevalence of Autism Spectrum Disorder is increasing day by day. There is no treatment for Autism Spectrum Disorder in light of the latest data. The applications made are primarily aimed at reducing stereotypical behaviors. Children with Autism Spectrum Disorder often experience gastrointestinal complaints such as diarrhea, constipation, abdominal pain, bloating, and gas. In addition, children with ASD also experience food selectivity, restrictive/avoidant feeding disorder, food neophobia, and nutritional problems due to sensory sensitivity. Considering these conditions, it is thought that dietary therapy may also be effective in the symptomatic treatment of Autism Spectrum Disorder with the support of studies conducted in recent years.
The Gluten-free Casein-free diet developed for Autism Spectrum Disorder is among the most researched diets. This diet is based on the elimination of foods containing gluten and casein. Although the other diet discussed in this study, the Feingold Diet, was developed initially for Attention Deficit and Hyperactivity Disorder, it is thought that it may be effective in symptomatic treatment due to enzyme deficiency in children with ASD. However, there are not enough studies on it. This study aimed to examine the effects of the Gluten-Casein-Free Diet and the Feingold Diet on gastrointestinal complaints in children with Autism Spectrum Disorder using the Scale of Eating Time Behaviors in Children with Autism (BAMBI), the Gastrointestinal Sensitivity Index and the Quality of Life Scale for Children. The study was planned to be conducted with 45 children with ASD between the ages of 3-10 registered at the Efeler Autism Life Center affiliated with the Efeler District Municipality of Aydın Province. Therefore, the necessary permissions will be obtained from the Efeler Autism Life Center, and the study will be submitted to the ethics committee for approval. The research data will be analyzed using the SPSS 22 (Statistical Package for the Social Sciences) program. Numbers and percentage distributions for descriptive feature data; correlation analyses will be used to determine the relationship and analyses appropriate for nonparametric and parametric data between the data.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Different Dietary Practices
- Keywords
- Quality of Life, Eating Behavior, Autism Spectrum Disorder, gluten-free-casein-free diet, feingold diet
- Medical subject headings
- Autism Spectrum Disorder, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different Dietary PracticesOther
The aim was to investigate the effects of Gluten-Casein-Free Diet and Feingold Diet on gastrointestinal complaints in children with Autism Spectrum Disorder.
| Study group | Role | What they receive |
|---|---|---|
| Gluten-Free-Casein-Free Diet | Experimental | The Gluten-free Casein-free diet is one of the most researched diets for Autism Spectrum Disorder. This diet is based on the elimination of foods containing gluten and casein. In this arm, children between the ages of 3 and 10 will be subjected to a Gluten-free-Casein-free diet for 12 weeks. Children will be controlled for compliance with the diet every two weeks. Receives: Other: Different Dietary Practices |
| Feingold Diet | Experimental | The Feingold Diet was originally developed for Attention Deficit and Hyperactivity Disorder, it is thought to be effective in symptomatic treatment due to enzyme deficiency in children with Autism Spectrum Disorder, but there are not enough studies on it. The Feingold Diet is one of the most researched diets for Autism Spectrum Disorder. This diet is based on the elimination of foods containing gluten and casein. In this arm, children between the ages of 3 and 10 will be subjected to a the Feingold Diet diet for 12 weeks. Children will be controlled for compliance with the diet every two weeks. Receives: Other: Different Dietary Practices |
| Control | No intervention | the arm receives no intervention during the study. (CONTROL GROUP). Children in this group will be monitored every 2 weeks for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
It will be evaluated whether there is a difference in the effects of the gluten-free-casein-free diet and the Feingold Diet on the gastrointestinal system. The evaluation will be made using the Gastrointestinal Sensitivity Index.
Gastrointestinal Sensitivity Index: The GI sensitivity index assesses 0-17 points. A score of seven and above is a severe symptom in the child. The Gastrointestinal Sensitivity Index is applied by hospital personnel. It was prepared to examine children's digestive problems and their changes according to periods. The test consists of nine headings under the heading of symptoms: "Constipation, Diarrhea, Average Stool Density, Abdominal Hardness, Stool Odor, Flatulence, Abdominal Pain, Unexplained Daytime Irritability, Nighttime Awakening, and Abdominal Hardness." Each heading was matched with the answers numbered "0, 1, 2" and the sensitivity index was obtained.
Measured: Baseline and 3 months
Eating behaviors
It will examine whether there is a difference between the effects of the gluten-free-casein-free diet and the Feingold Diet on eating behavior.
Brief Autism Mealtime Behaviors Inventory (BAMBI): It was adapted into Turkish by Meral and Fidan in 2014. The scale consists of 18 items. It consists of three subscales: limited food variety, refusal, and autism-related behavioral characteristics. Items 3, 9, 10, and 15 are reverse-scored. Each item is scored as 1 for never, 2 for rarely/rarely, 3 for occasionally/sometimes, 4 for often, and 5 for always, according to its frequency of occurrence. The BAMBI-total score and subscale scores are as follows: For the limited food variety score, the total score of items 10, 11, 13, 14, 15, 16, 17, and 18 is evaluated; for the food refusal score, the total score of items 1, 2, 4, 7 and 8 is evaluated; and for the autism-specific behavior score, the total score of items 3, 5, 6, 9 and 12 is evaluated. High scores from the total and subscales indicate
Measured: Baseline and 3 months
Pediatric Quality of Life
It will examine whether there is a difference between the effects of the gluten-free-casein-free diet and the Feingold Diet on quality of life.
The Pediatric Quality of Life Inventory (PedsQL): The Children's Quality of Life Questionnaire (PedsQL) was developed by Varni and colleagues in 1999 to assess the health-related quality of life of children and adolescents between the ages of 2 and 18. The scale has four separate forms organized according to age group characteristics for the 2-4, 5-7, 8-12, and 13-18 age groups. The Turkish validity and reliability studies of the forms for the 5-7 age group were conducted by Üneri et al., and the Turkish validity and reliability studies of the forms for the 8-12 and 13-18 age groups were conducted by Memik et al. The scale, which has a parent-only form for the 2-4 age group, has both parent and child forms for other age groups. The scale has four subscales that question physical, emotional, social, and school-related functionality. While a fi
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Gürel, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852027
- Sponsor's protocol ID
- E-15189967-050.04-593675
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Dietary Practices on Quality of Life and Eating Behavior in Children with Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06852027
- Acronym / sponsor ID
- E-15189967-050.04-593675
- Conditions
- Autism Spectrum Disorder
- Keywords
- Quality of Life, Eating Behavior, Autism Spectrum Disorder, gluten-free-casein-free diet, feingold diet
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Feb 2025 (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.
The aim of this study is to investigate the effects of gluten-free casein-free diet and feingold diet on gastrointestinal system (GI) symptoms , eating behavior and quality of life in children with autism spectrum disorder. Research questions are below:
Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on GI symptoms? Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on eating behavior? Is there a difference in the effects of a gluten-free-casein-free diet and the Feingold Diet on quality of life?
Detailed description
Autism Spectrum Disorder is defined as different neurodevelopmental disorders characterized by social communication, restrictive, repetitive, and typical behaviors and interests. Although it is not known precisely how the disease develops, literature reviews see genetic and environmental factors as the leading causes. The prevalence of Autism Spectrum Disorder is increasing day by day. There is no treatment for Autism Spectrum Disorder in light of the latest data. The applications made are primarily aimed at reducing stereotypical behaviors. Children with Autism Spectrum Disorder often experience gastrointestinal complaints such as diarrhea, constipation, abdominal pain, bloating, and gas. In addition, children with ASD also experience food selectivity, restrictive/avoidant feeding disorder, food neophobia, and nutritional problems due to sensory sensitivity. Considering these conditions, it is thought that dietary therapy may also be effective in the symptomatic treatment of Autism Spectrum Disorder with the support of studies conducted in recent years.
The Gluten-free Casein-free diet developed for Autism Spectrum Disorder is among the most researched diets. This diet is based on the elimination of foods containing gluten and casein. Although the other diet discussed in this study, the Feingold Diet, was developed initially for Attention Deficit and Hyperactivity Disorder, it is thought that it may be effective in symptomatic treatment due to enzyme deficiency in children with ASD. However, there are not enough studies on it. This study aimed to examine the effects of the Gluten-Casein-Free Diet and the Feingold Diet on gastrointestinal complaints in children with Autism Spectrum Disorder using the Scale of Eating Time Behaviors in Children with Autism (BAMBI), the Gastrointestinal Sensitivity Index and the Quality of Life Scale for Children. The study was planned to be conducted with 45 children with ASD between the ages of 3-10 registered at the Efeler Autism Life Center affiliated with the Efeler District Municipality of Aydın Province. Therefore, the necessary permissions will be obtained from the Efeler Autism Life Center, and the study will be submitted to the ethics committee for approval. The research data will be analyzed using the SPSS 22 (Statistical Package for the Social Sciences) program. Numbers and percentage distributions for descriptive feature data; correlation analyses will be used to determine the relationship and analyses appropriate for nonparametric and parametric data between the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluten-Free-Casein-Free Diet | Experimental | Other: Different Dietary PracticesThe Gluten-free Casein-free diet is one of the most researched diets for Autism Spectrum Disorder. This diet is based on the elimination of foods containing gluten and casein. In this arm, children between the ages of 3 and 10 will be subjected to a Gluten-free-Casein-free diet for 12 weeks. Children will be controlled for compliance with the diet every two weeks. |
| Feingold Diet | Experimental | Other: Different Dietary PracticesThe Feingold Diet was originally developed for Attention Deficit and Hyperactivity Disorder, it is thought to be effective in symptomatic treatment due to enzyme deficiency in children with Autism Spectrum Disorder, but there are not enough studies on it. The Feingold Diet is one of the most researched diets for Autism Spectrum Disorder. This diet is based on the elimination of foods containing gluten and casein. In this arm, children between the ages of 3 and 10 will be subjected to a the Feingold Diet diet for 12 weeks. Children will be controlled for compliance with the diet every two weeks. |
| Control | No intervention | –the arm receives no intervention during the study. (CONTROL GROUP). Children in this group will be monitored every 2 weeks for 12 weeks. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Different Dietary PracticesThe aim was to investigate the effects of Gluten-Casein-Free Diet and Feingold Diet on gastrointestinal complaints in children with Autism Spectrum Disorder. | Other | Feingold Diet, Gluten-Free-Casein-Free Diet |
Primary outcome
Gastrointestinal symptoms
Time frame: Baseline and 3 months
It will be evaluated whether there is a difference in the effects of the gluten-free-casein-free diet and the Feingold Diet on the gastrointestinal system. The evaluation will be made using the Gastrointestinal Sensitivity Index. Gastrointestinal Sensitivity Index: The GI sensitivity index assesses 0-17 points. A score of seven and above is a severe symptom in the child. The Gastrointestinal Sensitivity Index is applied by hospital personnel. It was prepared to examine children's digestive problems and their changes according to periods. The test consists of nine headings under the heading of symptoms: "Constipation, Diarrhea, Average Stool Density, Abdominal Hardness, Stool Odor, Flatulence, Abdominal Pain, Unexplained Daytime Irritability, Nighttime Awakening, and Abdominal Hardness." Each heading was matched with the answers numbered "0, 1, 2" and the sensitivity index was obtained.
Eating behaviors
Time frame: Baseline and 3 months
It will examine whether there is a difference between the effects of the gluten-free-casein-free diet and the Feingold Diet on eating behavior. Brief Autism Mealtime Behaviors Inventory (BAMBI): It was adapted into Turkish by Meral and Fidan in 2014. The scale consists of 18 items. It consists of three subscales: limited food variety, refusal, and autism-related behavioral characteristics. Items 3, 9, 10, and 15 are reverse-scored. Each item is scored as 1 for never, 2 for rarely/rarely, 3 for occasionally/sometimes, 4 for often, and 5 for always, according to its frequency of occurrence. The BAMBI-total score and subscale scores are as follows: For the limited food variety score, the total score of items 10, 11, 13, 14, 15, 16, 17, and 18 is evaluated; for the food refusal score, the total score of items 1, 2, 4, 7 and 8 is evaluated; and for the autism-specific behavior score, the total score of items 3, 5, 6, 9 and 12 is evaluated. High scores from the total and subscales indicate
Pediatric Quality of Life
Time frame: Baseline and 3 months
It will examine whether there is a difference between the effects of the gluten-free-casein-free diet and the Feingold Diet on quality of life. The Pediatric Quality of Life Inventory (PedsQL): The Children's Quality of Life Questionnaire (PedsQL) was developed by Varni and colleagues in 1999 to assess the health-related quality of life of children and adolescents between the ages of 2 and 18. The scale has four separate forms organized according to age group characteristics for the 2-4, 5-7, 8-12, and 13-18 age groups. The Turkish validity and reliability studies of the forms for the 5-7 age group were conducted by Üneri et al., and the Turkish validity and reliability studies of the forms for the 8-12 and 13-18 age groups were conducted by Memik et al. The scale, which has a parent-only form for the 2-4 age group, has both parent and child forms for other age groups. The scale has four subscales that question physical, emotional, social, and school-related functionality. While a fi
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Different Dietary Practices in people with Autism Spectrum Disorder, run by Aydin Adnan Menderes University 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?
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: enrolling by invitation, as of the sponsor's last update on 28 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gastrointestinal symptoms (time frame: Baseline and 3 months). 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?
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 28 Feb 2025.