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

NCT07089498 | Completed

• 1 other identifier: 2557
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

  Six weeks

• Evaluation of quality of life (SF-36)

  Six weeks

• Evaluation of mental health (SCL-90)

  Six weeks

Study Arms (2)

Low Fodmap Gluten Free Diet

EXPERIMENTAL

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)

Regular Gluten Free Diet

NO INTERVENTION

Patients received a table containing a list of allowed food based on a regular diet

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

Low Fodmap Gluten Free Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• patients who have not given informed consent
• patients without a diagnosis of a functional gastrointestinal disorder

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (2)

Leda Roncoroni

Milan, 20100, Italy

Location

Luca Elli

Milan, 20100, Italy

Location

Related Publications (6)

• 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.

  PMID: 24443070 BACKGROUND

• 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.

  PMID: 16457124 BACKGROUND

• 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.

  PMID: 9817120 BACKGROUND

• 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.

  PMID: 21334861 BACKGROUND

• 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.

  PMID: 22588748 BACKGROUND

• 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.

  PMID: 30012987 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Luca Elli, PhD, MD

  IRCCS Maggiore H

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: July 28, 2025
• Study Start: February 3, 2021
• Primary Completion: November 30, 2023
• Study Completion: April 30, 2024
• Last Updated: July 28, 2025

Record last verified: 2022-12

Locations

IT (2)