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

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders

• Registration Number: NCT07089498
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-02-03
• Status Verified: 2022-12
• Study First Submitted: 2023-01-04
• Primary Completion: 2023-11-30
• Study Completion: 2024-04-30
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Six weeks	Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet

Secondary Outcome Measures

Name	Time	Method
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	Six weeks	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
Evaluation of gastrointestinal symptoms (VAS)	Six weeks	Evaluation of gastrointestinal symptoms through Visual Analogue Scale (VAS) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2)
Evaluation of quality of life (SF-36)	Six weeks	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)
Evaluation of mental health (SCL-90)	Six weeks	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)

Trial Locations

Locations (2)

Leda Roncoroni; 🇮🇹 Milan, Italy

Luca Elli; 🇮🇹 Milan, Italy