Functional Gastrointestinal DisordersNCT07089498
13C-Octanoic Acid Breath Test on Gastric Emptying in Celiac Patients With Functional Disorders
A study testing Dietary Intervention (Low Fodmap Gluten Free Diet) in people with Functional Gastrointestinal Disorders, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Dietary Intervention (Low Fodmap Gluten Free Diet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesItaly
- Study dates
- 3 Feb 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- patients who have not given informed consent
- patients without a diagnosis of a functional gastrointestinal disorder
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Dietary Intervention (Low Fodmap Gluten Free Diet)
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start3 Feb 2021
- Primary completion30 Nov 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Elli, PhD, MD, Principal investigator, IRCCS Maggiore H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089498
- Sponsor's protocol ID
- 2557
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24443070Usai 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.
PubMed 16457124Apolone 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.
PubMed 9817120Prunas 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.
PubMed 21334861Hawker 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.
PubMed 22588748Massironi 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.
PubMed 30012987
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13C-Octanoic Acid Breath Test for the Evaluation of a Low-fodmaps Diet on Gastric Emptying in Celiac Patients With Functional Disorders
- ClinicalTrials.gov ID
- NCT07089498
- Acronym / sponsor ID
- 2557
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Fodmap Gluten Free Diet | Experimental | Other: Dietary Intervention (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 |
| Regular Gluten Free Diet | No intervention | –Patients received a table containing a list of allowed food based on a regular diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- patients who have not given informed consent
- patients without a diagnosis of a functional gastrointestinal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Low Fodmap Gluten Free Diet |
Primary outcome
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
4 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)
Time frame: Six weeks
Evaluation of quality of life (SF-36)
Time frame: Six weeks
Evaluation of mental health (SCL-90)
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 24443070Bruno 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.
- Background: PubMed 16457124Usai 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.
- Background: PubMed 9817120Apolone 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.
- Background: PubMed 21334861Prunas 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.
- Background: PubMed 22588748Hawker 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.
- Background: PubMed 30012987Massironi 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.
Related trials for Functional Gastrointestinal Disorders
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Elli, PhD, MD principal investigator
IRCCS Maggiore H
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention (Low Fodmap Gluten Free Diet) in people with Functional Gastrointestinal Disorders, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089498, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.