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Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver

NCT04575506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-13

No results posted yet for this study

Summary

The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Obesity
  • Metabolic Syndrome

Interventions

OTHER

Multidisciplinary intervention program

The intervention program includes an educational program promoting healthy dietary habits and physical activity (nutritionist and exercise physiologist) (2 times/month, for children and parents), and supervised home-based exercise (from 3 to 5 times/week, 38-44 min) program for 12-weeks.

Sponsors & Collaborators

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Universidad Pública de Navarra

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-09-30
Completion
2021-12-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575506 on ClinicalTrials.gov