Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07888998
NA

Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients

Sponsor: Acibadem University

View on ClinicalTrials.gov

Summary

The aim of this randomized controlled study is to evaluate the effects of a six-week low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet on gastrointestinal symptoms, inflammatory biomarkers, nutritional status, and quality of life in pediatric and adult patients with Fabry disease. A total of 30 patients with genetically or laboratory-confirmed Fabry disease are planned to be enrolled and randomly assigned to either an intervention group receiving an individualized low-FODMAP diet or a control group continuing their habitual diet. Assessments will be conducted at baseline and after six weeks. Gastrointestinal symptoms, stool characteristics, quality of life, anthropometric measurements, body composition, dietary intake, and biochemical parameters, including inflammatory biomarkers, will be evaluated. The study aims to investigate whether a low-FODMAP diet may provide additional benefits in managing gastrointestinal manifestations and inflammation in patients with Fabry disease.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-02

Completion Date

2027-02-28

Last Updated

2026-10-26

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Low-FODMAP Diet

Participants assigned to the intervention group will follow an individualized low-FODMAP diet for six weeks. The dietary intervention will be tailored to participants' age, sex, and energy requirements. Foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols, including excess fructose, lactose, fructans, galacto-oligosaccharides, and polyols, will be restricted and replaced with suitable low-FODMAP alternatives. Participants will receive individualized meal plans, and dietary adherence will be monitored through daily online follow-up sessions throughout the intervention period.

Locations (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)