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Search / Trial NCT06491836

Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).

Launched by AIN SHAMS UNIVERSITY · Jul 4, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different diets on children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). The trial will involve 50 children aged 6 to 16 who have been diagnosed with ADHD according to specific guidelines. These children will be randomly divided into two groups: one group will follow a regular diet that meets their nutritional needs without any restrictions, while the other group will follow a special diet called the Oligoantigenic diet, which limits certain foods that could be causing their symptoms. Researchers will assess the children's mental health before starting the diets and then again after three months to see if there are any changes.

To join this trial, children must have a formal ADHD diagnosis and be stable on their current medications for at least eight weeks before starting the study. The trial is not open yet for enrollment, and it's important to note that children with other serious medical conditions or significant learning disabilities (an IQ below 80) will not be eligible to participate. This study aims to better understand if dietary changes can help improve the core symptoms of ADHD in children.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children fulfilled DSM (5) Criteria for ADHD syndrome aged from 6 to 16 years old on stable pharmacotherapy 8 weeks prior to enrollment with intention to maintain ongoing therapies constant throughout the trial.
  • Exclusion Criteria:
  • Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
  • Intelligence quotient (IQ) of patients less than 80%.

About Ain Shams University

Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported