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

13C-Octanoic Acid Breath Test for the Evaluation of a Low-fodmaps Diet 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.

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Other: Dietary Intervention (Low Fodmap Gluten Free Diet)

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20100
    • Leda Roncoroni
  • Milan, Italy, 20100
    • Luca Elli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Fodmap Gluten Free Diet; Patients received dietary advice in the form of a table divided into two columns, one reporting the allowed food because low in FODMAPs and the other indicating the prohibited food due to its high continent of FODMAPs	Other: Dietary Intervention (Low Fodmap Gluten Free Diet); The intervention provides the administration of a Low Fodmap Diet to celiac or non celiac patients with functional gastrointestinal disorders
No Intervention: Regular Gluten Free Diet; Patients received a table containing a list of allowed food based on a regular diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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)	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)	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)	Six weeks

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Luca Elli, PhD, MD, IRCCS Maggiore H

Publications and helpful links

General Publications

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
• Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
• Bruno G, Lopetuso LR, Ianiro G, Laterza L, Gerardi V, Petito V, Poscia A, Gasbarrini A, Ojetti V, Scaldaferri F. 13C-octanoic acid breath test to study gastric emptying time. Eur Rev Med Pharmacol Sci. 2013;17 Suppl 2:59-64.
• Usai Satta P, Scarpa M, Oppia F, Loriga F. 13C-octanoic acid breath test in functional and organic disease: critical review of literature. Eur Rev Med Pharmacol Sci. 2005 Sep-Oct;9(5 Suppl 1):9-13.
• Prunas A, Sarno I, Preti E, Madeddu F, Perugini M. Psychometric properties of the Italian version of the SCL-90-R: a study on a large community sample. Eur Psychiatry. 2012 Nov;27(8):591-7. doi: 10.1016/j.eurpsy.2010.12.006. Epub 2011 Feb 21.
• Massironi S, Branchi F, Fraquelli M, Baccarin A, Somalvico F, Ferretti F, Conte D, Elli L. Effects of a Gluten-Containing Meal on Gastric Emptying and Gallbladder Contraction. Nutrients. 2018 Jul 16;10(7):910. doi: 10.3390/nu10070910.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2557

Drug and device information, study documents

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