13C-Octanoic Acid Breath Test on Gastric Emptying in Celiac Patients With Functional Disorders

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico68 enrolled

Overview

The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders.

The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders. The aims of the study are: * Evaluation of gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia. * Evaluation of gastrointestinal symptoms, quality of life, and mental health in patients with non-celiac and celiac functional disorders pre- and post-diet (T1 and T2). Participants: * Will run the 13C-octanoic acid breath test pre- and post-diet * Will complete the VAS, SF-36, and SCL-90 questionnaires pre- and post-diet * Will follow a low fodmap gluten free diet or a regular gluten-free diet for six weeks Researchers will compare celiac and non-celiac patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Functional Gastrointestinal Disorders

Interventions

Dietary Intervention (Low Fodmap Gluten Free Diet)OTHER

The intervention provides the administration of a Low Fodmap Diet to celiac or non celiac patients with functional gastrointestinal disorders

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age: ≥ 18 years old * gender: male or female * patients who have signed informed consent * patients diagnosed with a functional gastrointestinal disorder who meet Rome IV criteria (according to Rome Foundation's latest revision of 2016) Exclusion Criteria: * patients who have not given informed consent * patients without a diagnosis of a functional gastrointestinal disorder

Locations (2)

Leda Roncoroni

Milan, Italy

Luca Elli

Milan, Italy

Outcomes

Primary Outcomes

Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia

Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet

Time frame: Six weeks

Secondary Outcomes

Comparison of the effects of dietary recommendation for a diet low in Oligo-, Di- and Monosaccharides and Polyols (FODMAPs) or a balanced diet in celiac and non-celiac dyspeptic patients on gastric emptying time

Time frame: Six weeks

Evaluation of gastrointestinal symptoms (VAS)

Evaluation of gastrointestinal symptoms through Visual Analogue Scale (VAS) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2)

Time frame: Six weeks

Evaluation of quality of life (SF-36)

Evaluation of quality of life through a questionnaire on the health state (Short Form Health Survey, SF-36) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2)

Time frame: Six weeks

Evaluation of mental health (SCL-90)

Evaluation of mental health through a questionnaire on the health state (Symptom Check List, SCL-90) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2)

Time frame: Six weeks

Data from ClinicalTrials.gov

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