Clinical Trial

Meals, Microbiota & Mental Health of Children & Adolescents

Study acronym: MMM
Not Yet Recruiting
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Record status
This record was last updated February 8, 2024 (before its estimated March 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
Recent studies indicate that the interplay between diet, intestinal microbiota composition, and intestinal permeability might impact mental health. The aim of thisl study is to compare diet, intestinal microbiota, intestinal permeability, and related metabolic factors among children and adolescents diagnosed with mental health disorders and control groups and identify potential relationship patterns. All children and adolescents referred to the outpatient clinic at the Child and Adolescent Psychiatry Department at The National University Hospital in Reykjavik Iceland will be offered to participate (n=15) (age 5-15 years). Two control groups will be used; the same parent siblings close in age (n=x) as well as age and sex-matched children from the same postal area (n=15). A three-day food diary, rating scales for mental health and multiple questionnaires will be completed as well as faecal sample, buccal swab, urine, saliva and blood samples will be collected. This is a novel approach as more multidimensional transdisciplinary studies including longitudinal observational data have been called for as a basis for lifestyle treatment options for improving mental health and wellness.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-03-31; most recent amendment 2024-02-07.
Trial Details
NCT Number NCT04330703
Lead Sponsor University of Iceland
Collaborators: Landspitali University Hospital
Conditions Mental Disorder
Enrollment 30 participants
Start Date 2024-03-15
Primary Completion 2025-03-15 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-02-08