Autism Spectrum DisorderNCT05848336
The Gluten-Casein-free Diet in Children With Autism: A Clinical Results of the Ophthalmic and Behavioral Manifestations
A study testing Gluten Free Casein Free Diet in people with Autism Spectrum Disorder and Ophthalmic Abnormalities, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the efficacy of eight weeks of GFCF in children with ASD on autistic symptoms and ophthalmic findings such as corneal reflex, interpupillary distance (IPD) and pupil size. Read more about this study
- Who is it for?
- Ages 2 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Ophthalmic Abnormalities
- What is being tested?
- Gluten Free Casein Free Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2020to 18 Jan 2023
- Phase
- Interventional
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
- Children, male or female, 2 to 11 years old (inclusive)
- Confirmed diagnosis of ASD according to the DSM-IV Symptom Checklist
- Ability to maintain a gluten- and casein-free diet during the study
Who cannot join
- Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
- Children with any drug use
- Children currently receiving treatment with any alternative medical methods (eg.hyperbaric).
- Children with a diagnosis of celiac disease
- Children who have received any dietary treatment before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gluten-free, Casein-free Diet in Children With Autism
To evaluate the efficacy of eight weeks of GFCF in children with ASD on autistic symptoms and ophthalmic findings such as corneal reflex, interpupillary distance (IPD) and pupil size.
Read the detailed description
Autism spectrum disorder (ASD) is a common condition. ASD is a heritable illness characterized by early-onset differences in interaction, communication, sensory atypicality, and stereotyped behaviors. Recent studies suggest a link between elimination diets and severity of autistic behaviors. The etiology of ASD has been still uncertain. Therefore, elucidating the underlying pathology may assist in risk assessment and facilitate process management. Non-harmful and existing evidence for the diet's benefits in ASD must be elucidated.
Primary Study Objective:
To assess the effect of a GFCF diet on variables autism index, stereotyped behaviors, communication, social interaction associated with ASD.
The pupillary response can be utilized to anticipate neurological and physiological activities under the surface. Changes in light trigger the pupil response, which adjusts the amount of brightness falling on the retina by instinctively constricting or dilating the pupil. Atypical pupil size has been linked to abnormal autonomic function in people with ASD. Disturbances in autonomic functions may also lead to differences in the corneal reflex. This study aimed to obtain more data on the behavioral symptoms and ophthalmic measurements of gluten-free casein-free (GFCF) on ASD. In addition, normal development children and children with autism may differ in facial morphology. This study also evaluates the effect of GFCF diet on IPD distance.
Secondary Objectives:
To assess the role of GFCF diet in the manifestation of opthalmic measurements such as pupil size, corneal reflex and IPD.
30 children with ASD were enrolled in a 8-weeks prospective GFCF diet treatment study. In the study, a single group was evaluated with measurements before and after dietary intervention.
- Conditions
- Autism Spectrum Disorder, Ophthalmic Abnormalities
- Being tested
- Gluten Free Casein Free Diet
- Keywords
- gluten free casein free diet
- 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.
Gluten Free Casein Free DietBehavioural
Thirty children with autism were evaluated before the diet (Pre-Test) and after 8 weeks of dietary intervention (Post-Test).
| Study group | Role | What they receive |
|---|---|---|
| Gluten Free Casein Free Diet | Experimental | Foods containing gluten (pasta, bread, etc.), casein (unfermented dairy products), and their disguised sources have been eliminated from the nutrition program. Also, packaged foods (chocolate, crackers, etc.) containing additives such as artificial preservatives, food coloring, and sweeteners that create a tendency to consume in children were avoided from the nutrition program. Goat milk contains type A2 casein, and most of the casein is digested in fermented dairy products. In order to increase calcium intake, the consumption of some foods (dill, kale, spinach, chard, arugula, broccoli, parsley, legumes, nuts, tahini, etc.) has been increased. Elimination was done gradually, considering nervousness, anxiety, etc., due to the effects of opioid mechanisms of action and gastrointestinal system symptoms. Receives: Behavioral: Gluten Free Casein Free Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gilliam Autism Rating Scale 2 (GARS-2)
Based on DSM-IV autism diagnostic criteria, GARS-2 is a behavior checklist for children and teenagers aged 3 to 22. The three subscales of the scale are communication, social interaction, and stereotypical behavior. Each subscale contains 14 items that are scored on a four-point scale (0: Never observed, 1: Rarely observed, 2: Sometimes observed, 3: Often observed). The total score obtained from the scale is converted into standard scores, and an OBI score is obtained. An OBI score of 85 and above indicates a high probability of having ASD, a score between 70-84 indicates a medium probability, and a score of 69 and below indicates a low probability.
Measured: 8 weeks
Weight (kg)
Body weight was measured in kilograms.
Measured: 8 weeks
Body mass index
Body mass index (BMI)=weight/(height)^2
Measured: 8 weeks
Secondary outcomes (1)
The pupil measurements
The measurements of both groups were taken from a distance of 1 meter with a binocular photo refractometer under the same conditions, without cycloplegia. Plusoptix® A09 an measure a pupil size of 4.0-8.0 mm in 0.1 mm steps. Eccentric photorefraction is used as a measurement basis. The device provides convenience in terms of pediatric evaluation with its remarkable features. The pupil measurements were performed by an ophthalmologist in the outpatient clinical unit. The brightness level in the room was controlled via the lux meter application. Pupil size (mm) was measured at least three times after each participant was left in a room with a light level of 8 cd/m2 for 2 minutes. The average value of 3 consecutive consistent measurements was recorded.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start26 Nov 2020
- Primary completion14 Mar 2022
- Study completion18 Jan 2023
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Karahan, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848336
- Sponsor's protocol ID
- UskudarUGFCFAUTISM
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 8 May 2023
- 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 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gluten-free, Casein-free Diet in Children With Autism
- ClinicalTrials.gov ID
- NCT05848336
- Acronym / sponsor ID
- UskudarUGFCFAUTISM
- Conditions
- Autism Spectrum Disorder, Ophthalmic Abnormalities
- Keywords
- gluten free casein free diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 8 May 2023 (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.
To evaluate the efficacy of eight weeks of GFCF in children with ASD on autistic symptoms and ophthalmic findings such as corneal reflex, interpupillary distance (IPD) and pupil size.
Detailed description
Autism spectrum disorder (ASD) is a common condition. ASD is a heritable illness characterized by early-onset differences in interaction, communication, sensory atypicality, and stereotyped behaviors. Recent studies suggest a link between elimination diets and severity of autistic behaviors. The etiology of ASD has been still uncertain. Therefore, elucidating the underlying pathology may assist in risk assessment and facilitate process management. Non-harmful and existing evidence for the diet's benefits in ASD must be elucidated.
Primary Study Objective:
To assess the effect of a GFCF diet on variables autism index, stereotyped behaviors, communication, social interaction associated with ASD.
The pupillary response can be utilized to anticipate neurological and physiological activities under the surface. Changes in light trigger the pupil response, which adjusts the amount of brightness falling on the retina by instinctively constricting or dilating the pupil. Atypical pupil size has been linked to abnormal autonomic function in people with ASD. Disturbances in autonomic functions may also lead to differences in the corneal reflex. This study aimed to obtain more data on the behavioral symptoms and ophthalmic measurements of gluten-free casein-free (GFCF) on ASD. In addition, normal development children and children with autism may differ in facial morphology. This study also evaluates the effect of GFCF diet on IPD distance.
Secondary Objectives:
To assess the role of GFCF diet in the manifestation of opthalmic measurements such as pupil size, corneal reflex and IPD.
30 children with ASD were enrolled in a 8-weeks prospective GFCF diet treatment study. In the study, a single group was evaluated with measurements before and after dietary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gluten Free Casein Free Diet | Experimental | Behavioral: Gluten Free Casein Free DietFoods containing gluten (pasta, bread, etc.), casein (unfermented dairy products), and their disguised sources have been eliminated from the nutrition program. Also, packaged foods (chocolate, crackers, etc.) containing additives such as artificial preservatives, food coloring, and sweeteners that create a tendency to consume in children were avoided from the nutrition program. Goat milk contains type A2 casein, and most of the casein is digested in fermented dairy products. In order to increase calcium intake, the consumption of some foods (dill, kale, spinach, chard, arugula, broccoli, parsley, legumes, nuts, tahini, etc.) has been increased. Elimination was done gradually, considering nervousness, anxiety, etc., due to the effects of opioid mechanisms of action and gastrointestinal system symptoms. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Informed consent / Assent, as applicable must be signed prior to executing any study related procedure
- Children, male or female, 2 to 11 years old (inclusive)
- Confirmed diagnosis of ASD according to the DSM-IV Symptom Checklist
- Ability to maintain a gluten- and casein-free diet during the study
Key exclusion criteria (5 listed)
- Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
- Children with any drug use
- Children currently receiving treatment with any alternative medical methods (eg.hyperbaric).
- Children with a diagnosis of celiac disease
- Children who have received any dietary treatment before
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 |
|---|---|---|
| Gluten Free Casein Free DietThirty children with autism were evaluated before the diet (Pre-Test) and after 8 weeks of dietary intervention (Post-Test). | Behavioural | Gluten Free Casein Free Diet |
Primary outcome
Gilliam Autism Rating Scale 2 (GARS-2)
Time frame: 8 weeks
Based on DSM-IV autism diagnostic criteria, GARS-2 is a behavior checklist for children and teenagers aged 3 to 22. The three subscales of the scale are communication, social interaction, and stereotypical behavior. Each subscale contains 14 items that are scored on a four-point scale (0: Never observed, 1: Rarely observed, 2: Sometimes observed, 3: Often observed). The total score obtained from the scale is converted into standard scores, and an OBI score is obtained. An OBI score of 85 and above indicates a high probability of having ASD, a score between 70-84 indicates a medium probability, and a score of 69 and below indicates a low probability.
Weight (kg)
Time frame: 8 weeks
Body weight was measured in kilograms.
Body mass index
Time frame: 8 weeks
Body mass index (BMI)=weight/(height)^2
1 secondary outcome
The pupil measurements
Time frame: 8 weeks
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 8 May 2023.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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?
A study testing Gluten Free Casein Free Diet in people with Autism Spectrum Disorder and Ophthalmic Abnormalities, run by Uskudar 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?
The sponsor lists 4 inclusion and 5 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 8 May 2023. 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?
Gilliam Autism Rating Scale 2 (GARS-2) (time frame: 8 weeks). 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 8 May 2023.