Ireland
--:--IST
Enrolling by invitation Not applicable

Different Dietary Practices in Children with Autism Spectrum Disorder

NCT06852027 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-02
Last updated
2025-02-28

Condition(s) studied

Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

Different Dietary Practices

Different Dietary Practices: 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 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. 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?

Eligibility

Sex
ALL
Min age
3 Years
Max age
10 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Gastrointestinal symptoms — 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 — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
Aydin province Efeler Autism Life Center Aydin Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06852027 on ClinicalTrials.gov ↗ ← All trials in Turkey