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Completed

NCT Number: NCT07089498

13C-Octanoic Acid Breath Test 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.

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leda Roncoroni, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: Six weeks

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

Secondary outcomes

  1. 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

    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

  2. Evaluation of gastrointestinal symptoms (VAS)

    Time frame: 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)

  3. Evaluation of quality of life (SF-36)

    Time frame: 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)

  4. Evaluation of mental health (SCL-90)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

13C-Octanoic Acid Breath Test for the Evaluation of a Low-fodmaps Diet on Gastric Emptying in Celiac Patients With Functional Disorders

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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