Meals, Microbiota & Mental Health of Children & Adolescents

NCT04330703 | Not Yet Recruiting DMC

• 1 other identifier: UI-2019-MMM
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Mental Disorder

Keywords

Microbiota; Microbiome; Intestinal permeability; Children & adolescents; Mental health

Outcome Measures

Primary Outcomes (1)

• Intestinal permeability

  The prevalence of IP among cases

  One year

Study Arms (3)

Cases

Children and adolescents referred for their first visit to the outpatient clinic at the Child and Adolescent Psychiatry Department (BUGL) (n=15) will be invited to participate.

Contol

Age and sex-matched child from the same postal area (n=15).

Syblings

Same parent siblings close in age to the study subjects (cases only) (+3y) (n=x)

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children and adolescents (both genders; 5-15y) referred for their first visit to the outpatient clinic at the Child and Adolescent Psychiatry Department (BUGL) (n=150) will be invited to participate. Two control groups will be used; 1) Same parent siblings close in age to the study subjects (+3y) (n\<150) 2) Age and sex matched child from the same postal area (n=150).

You may qualify if:

• Children and adolescents (both genders; 5-15y) referred for their first visit to the outpatient clinic at the Child and Adolescent Psychiatry Department (BUGL)

You may not qualify if:

• A diagnosis of mental health disorder (ICD10)
• Antibiotics use for the last six months

Sponsors & Collaborators

• University of Iceland: lead
• Landspitali University Hospital: collaborator

Related Publications (1)

• Asbjornsdottir B, Lauth B, Fasano A, Thorsdottir I, Karlsdottir I, Gudmundsson LS, Gottfredsson M, Smarason O, Sigurdardottir S, Halldorsson TI, Marteinsson VT, Gudmundsdottir V, Birgisdottir BE. Meals, Microbiota and Mental Health in Children and Adolescents (MMM-Study): A protocol for an observational longitudinal case-control study. PLoS One. 2022 Sep 1;17(9):e0273855. doi: 10.1371/journal.pone.0273855. eCollection 2022.

  PMID: 36048886 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva (DNA and microbiome), urine, faeces (microbiota), deciduous teeth

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Bryndis E Birgisdottir, PhD

  University of Iceland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birna G Asbjornsdottir, MSc

CONTACT

3548982804; bga2@hi.is

Bryndis E Birgisdottir, PhD

CONTACT

3548592757; beb@hi.is

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: April 1, 2020
• Study Start: March 15, 2024
• Primary Completion: March 15, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 8, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share