Can Fecal Calprotectin Be Used as a Biomarker of Non-alcoholic Fatty Liver Disease In Obese Adolescents?

The incidence of non-alcoholic fatty liver disease (NAFLD) is increasing with obesity, and it is believed that ongoing inflammation in obesity and alterations in the enterohepatic axis contribute to this process. This study aimed to determine the role of fecal calprotectin (FCP) as an inflammatory biomarker in course of obesity and NAFLD.

Study Overview

• Status: Completed
• Conditions: NAFLD; Obesity, Childhood
• Intervention / Treatment: Diagnostic test: Fecal Calprotectin Test

Detailed Description

Obesity is a significant public health issue worldwide. With the increasing prevalence of obesity, the prevalence of metabolic syndrome in adolescents is also on the rise. Non-alcoholic fatty liver disease (NAFLD), a major cause of chronic liver disease, is the hepatic component of metabolic syndrome. The prevalence of NAFLD is not precisely known, but in some studies, it is between 22.5% and 52.8% in children with obesity, constituting 2.6% of all children. Although the mechanisms involved in the development of obesity-related metabolic complications and NAFLD are not well understood, it is believed that intestinal inflammation, changes in the microbiota, and alterations in the gut-liver axis (GLA) may play a role in the development of low-grade chronic inflammation in NAFLD associated with obesity. Fecal calprotectin (FCP), which has become increasingly important in demonstrating intestinal inflammation in recent years, is a widely used test, particularly in the diagnosis and monitoring of inflammatory bowel disease and various gastrointestinal disorders. In our study, the utility of FCP as an inflammatory biomarker in the course of NAFLD in obese adolescents has been investigated. The study was approved by our hospital's ethics committee in 15.11.2022 and another ethics committee approval was taken in 08.06.2023 for title change of study. This study conducted under the Helsinki Declaration.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 10-18 years old healthy adolescents for control group
• Children aged 10-18 years without any additional diseases, BMI>2 SD, no hepatosteatosis detected by ultrasonography (USG), and alanine aminotransferase (ALT) levels within normal limits were included in the obese group
• Children aged 10-18 years without any additional diseases, BMI>2 SD, Hepatosteatosis detected by ultrasonography (USG), and alanine aminotransferase (ALT) levels higher than normal limits adjusted for gender were included in the obese + NAFLD group

Exclusion Criteria:

• Diseases other than obesity and NAFLD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Fecal calprotectin samples taken for comparison from healthy adolescents	Diagnostic test: Fecal Calprotectin Test; Fecal samples are taken fom obese and healthy adolescents for study
Experimental: Obese group; Fecal calprotectin samples taken from obese adolescents	Diagnostic test: Fecal Calprotectin Test; Fecal samples are taken fom obese and healthy adolescents for study
Experimental: Obese + NAFLD group; Fecal calprotectin samples taken from obese adolescents that have NAFLD	Diagnostic test: Fecal Calprotectin Test; Fecal samples are taken fom obese and healthy adolescents for study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal Calprotectin Levels	Fecal calprotectin levels expected to be higher in obese adolescents, even higher in obese + NAFLD adolescents	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine Aminotransferase (ALT) Levels	ALT levels expected to be higher in NAFLD adolescents	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Director: Ayşe Merve Usta, M.D., Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Liver Diseases; Fatty Liver; Pediatric Obesity; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 15.11.2022-2124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No