Viewing Study NCT06636240



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06636240
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-10

Brief Title: Prebiotic Effects of Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
Sponsor: None
Organization: None

Study Overview

Official Title: Study on the Potential Prebiotic Effects and Gut Microbiota Changes of Glucoside-enriched Mulberry Fruit in Children and Adolescents With Atopic Dermatitis
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This project proposes a randomized controlled human study to explore the prebiotic effects of consuming mulberry juice on atopic dermatitis in children and adolescents The study aims to investigate the potential of mulberry fruit as a human prebiotic This human study will recruit up to 120 participants from the Taipei Medical University Hospital commissioned by the Ministry of Health and Welfare Participants will be divided into experimental groups and a control group with a 3-month intervention involving five clinical assessments and three stool collections The goal is to compare the severity of atopic dermatitis gut microbiota and metabolite changes during the 3 months of mulberry juice consumption between the experimental and control groups

This project will help establish mulberry fruit as a potential human prebiotic and adjunctive treatment for alleviating atopic dermatitis in children
Detailed Description: The results of animal experiments have confirmed that mulberry fruit can improve atopic dermatitis Its anti-inflammatory response is associated with the regulation of innate immune pathways and the restoration of skin barrier function Additionally mulberry extract may have prebiotic effects altering the gut microbiota and metabolites to improve host health Currently mulberries are known to contain a significant amount of glucosides with interleukin-17 isomer modulation being a major component Therefore mulberry fruit may have immune-regulatory effects especially in Asian children and adolescents with elevated Th-17-related interleukin expression However it is paucity in research on the anti-inflammatory effects of mulberry fruit and its impact on gut microbiota in human atopic dermatitis

This project proposes a randomized controlled human study to explore the long-term effects of consuming mulberry juice on atopic dermatitis in children and adolescents as well as the composition of gut microbiota and metabolites The study aims to investigate the potential of mulberry fruit as a human prebiotic A randomized controlled human study will recruit up to 120 participants from the Taipei Medical University Hospital commissioned by the Ministry of Health and Welfare Participants will be divided into experimental groups and a control group with a 3-month intervention involving five clinical assessments and three stool collections The goal is to compare the severity of atopic dermatitis gut microbiota and metabolite changes during the 3 months of mulberry juice consumption between the experimental and control groups

This project will help establish mulberry fruit as a potential human prebiotic and adjunctive treatment for alleviating atopic dermatitis in children It will also lay the foundation for future research on effective component isolation and analysis elucidating the impact of mulberry fruit on the composition of the human gut microbiota and metabolites

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None