IBSNCT06618677
Efficacy of a Low FODMAP Diet in IBS Children and Impact on Urinary and Faecal Metabolome
A study testing LOW FODMAPs Diet in people with IBS and Functional Gastrointestinal Disorders, run by University of Bari at 1 site in Italy.
Trial summary
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with defecation, or changes in stool frequency or stool form . Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- IBS, Functional Gastrointestinal Disorders
- What is being tested?
- LOW FODMAPs Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 Dec 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 4 and 18 years; b) diagnosis of IBS according to Rome IV criteria; c) absence of other organic diseases; d) feeding via the oral route; e) ability to read and comprehend any employed questionnaires/scales; f) signed informed consent;
Who cannot join
- organic disease b)some other FGID (not IBS) or lactose intolerance c) having already followed an exclusion diet d)in case of pregnancy e)eating disorders f) prior surgery of the gastrointestinal tract g) neurodevelopmental disabilities
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270
Bari, Ba, 70126
About this study
Official title: Efficacy of a Low FODMAP Diet in IBS Children and Impact on Microbiota, Urinary and Faecal Metabolome
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with defecation, or changes in stool frequency or stool form .
The low FODMAPs diet (LFD) is a relatively new approach in the management of IBS and focuses on limiting intake of poorly absorbed carbohydrates.
Read more
FODMAPs are highly fermentable but poorly absorbed short-chain carbohydrates and polyols contained in a wide variety of foods. FODMAPs include oligosaccharides (fructans, fructo-oligosaccharides = FOS and galacto-oligosaccharides = GOS), disaccharides (lactose), monosaccharides (fructose), and polyols (sorbitol, mannitol, maltitol, xylitol, polydextrose, and isomalt).
Many studies and meta-analysis in adults have shown that a low FODMAPs diet is effective in reducing IBS symptoms, particularly bloating and abdominal pain. On the other hand, evidences in children are scarce.
Previous studies in adults have demonstrated differences in urine metabolites between IBS patients receiving LFD compared to a high FODMAP diet (HFD), providing interesting hypotheses for pathophysiological mechanisms in IBS.
Aim of this study is to evaluate the efficacy of a LFD on gastrointestinal symptoms in children with IBS. Moreover, the investigators will assess the impact of LFD vs a diet with a standard content of FODMAPs (SFD) on the fecal and urinary metabolomic profile of pediatric IBS patients.
This is a single center, prospective, single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari.
The trial includes four phases (run-in, low FODMAP diet, wash out and standard FODMAP diet). The run-in phase (weeks 1-2) aim to assess basal symptoms while on habitual diet and only symptomatic children (VAS\>3) will progress to the dietetic intervention trial.
Then patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet.
Read the detailed description
Single center, prospective, single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari Metabolomic analysis will be performed at Department of Soil, Plant and Food Science, University of Bari Aldo Moro.
The study will include all consecutive patients diagnosed with IBS according to the Rome IV criteria at Giovanni XXII Children's Hospital of Bari. The Giovanni XXII Children's Hospital of Bari is the tertiary referral center for the diagnosis and follow-up of gastrointestinal disorders in our region, covering an estimated population of 1400000 children, (National Institute of Statistics-https://www.istat.it accessed on 1 January 2023) with more than 10000 children followed up in the gastrointestinal clinic.
The trial includes four phases (run-in, low FODMAP diet, wash out and standard FODMAP diet). The run-in phase (weeks 1-2) aim to assess basal symptoms while on habitual diet and only symptomatic children (VAS\>3) will progress to the dietetic intervention trial.
Then patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet. The order of the dietetic regimens is established according a computer-generated randomization list.
Fecal and urinary samples for analyzing metabolome will be collected before interventions and at the end of each dietetic regimen.
The study adheres to the Declaration of Helsinki, was approved by the institutional ethical committee. All patients gave full written informed consent.
Dietetic intervention An experienced dietician will design two different dietetic regimens (SFD and LFD), as a tailored personalized menu of 2 weeks duration, with manual calculation of nutrients and kilocalories according child age and weight. At enrollment the dietician will explain the diets in detail to the families who will be not aware of the content of FODMAP (low vs. standard). Parents will be only advised that the purpose of the study is to "Assess whether changing the amount of certain foods in the diet could affects symptoms of IBS" and the concept of FODMAPs wont be never mentioned during the study. Both menus will be normocaloric and balanced in macro- and micronutrients in relation to the age of the patient under study, according to the main principles of the Mediterranean diet. All menus comprise five meals during the day: breakfast, snack, lunch, snack and dinner. Food options present in the menus will be agree between the dietician, parents and children.
The food intake will be recorded on a diary and the same dietician, during follow-up visits checked dietary compliance. A proper dietary adherence was defined if percentage of amount of food left was less than 10% and number of times non-compliant per week was less than 2.
- Conditions
- IBS, Functional Gastrointestinal Disorders
- Being tested
- LOW FODMAPs Diet
- Keywords
- FODMAPs, IBS
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOW FODMAPs DietOther
Also called STANDARD FODMAPs Diet
patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms started the wash-out period of two weeks and subsequently started the final 2-week period on standard or low FODMAP diet. The LFD will have a FODMAP content expressed in grams 0.15 g/kg/d FODMAPs (maximum 10 g/day) while the SFD will contain 0.7 g/kg/d FODMAPs (maximum 60 g/day).
| Study group | Role | What they receive |
|---|---|---|
| LOW FODMAP-wash out- STANDARD FODMAPs | Active comparator | Arm starting with low fodmap diet Receives: Other: LOW FODMAPs Diet |
| STANDARD FODMAPs-wash out-LOW FODMAP | Active comparator | Arm starting with standard fodmap diet Receives: Other: LOW FODMAPs Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
0-10
Measured: from running in and during all the dietetic treatment
Irritable bowel Syndrome-Severity score
Is a five-item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life, scoring from 0 to 500. Cut-off of to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS
Measured: 15 days
Secondary outcomes (1)
Fecal and urinary Metabolome
SCFA and VOCs
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for IBSStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- single center, prospective, single blind low versus standard FODMAPs diet trial with crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
- Investigators
- Ruggiero Francavilla, Prof, Principal investigator, Interdisciplinary department of Medicine Pediatric section. University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618677
- Sponsor's protocol ID
- IBS-FODMAP
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and CSR will be available on request via email (fernandacristofori@gmail.com)
Publications
Caponio GR, Celano G, Calabrese FM, Riezzo G, Orlando A, D'Attoma B, Ignazzi A, Vacca M, Porrelli A, Tutino V, De Angelis M, Giannelli G, Russo F. Evaluation of the Effects of the Tritordeum-Based Diet Compared to the Low-FODMAPs Diet on the Fecal Metabolome of IBS-D Patients: A Preliminary Investigation. Nutrients. 2022 Nov 2;14(21):4628. doi: 10.3390/nu14214628.
PubMed 36364888Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.
PubMed 25016597Staudacher HM, Lomer MCE, Farquharson FM, Louis P, Fava F, Franciosi E, Scholz M, Tuohy KM, Lindsay JO, Irving PM, Whelan K. A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial. Gastroenterology. 2017 Oct;153(4):936-947. doi: 10.1053/j.gastro.2017.06.010. Epub 2017 Jun 15.
PubMed 28625832Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
PubMed 27144632Cristofori F, Celano G, Dargenio VN, Apa CA, Amendolara M, Stella M, Castellaneta S, Barone M, Vacca M, De Angelis M, Francavilla R. Clinical trial: Efficacy of a Low FODMAP Diet in Paediatric Irritable Bowel Syndrome-A Randomised Crossover Trial With Exploratory Metabolomic Analysis. Aliment Pharmacol Ther. 2026 Jun;63(12):1592-1604. doi: 10.1111/apt.70718. Epub 2026 May 13.
PubMed 42124549
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Low FODMAP Diet in IBS Children and Impact on Microbiota, Urinary and Faecal Metabolome
- ClinicalTrials.gov ID
- NCT06618677
- Acronym / sponsor ID
- IBS-FODMAP
- Conditions
- IBS, Functional Gastrointestinal Disorders
- Keywords
- FODMAPs, IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Oct 2024 (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.
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with defecation, or changes in stool frequency or stool form .
The low FODMAPs diet (LFD) is a relatively new approach in the management of IBS and focuses on limiting intake of poorly absorbed carbohydrates.
FODMAPs are highly fermentable but poorly absorbed short-chain carbohydrates and polyols contained in a wide variety of foods. FODMAPs include oligosaccharides (fructans, fructo-oligosaccharides = FOS and galacto-oligosaccharides = GOS), disaccharides (lactose), monosaccharides (fructose), and polyols (sorbitol, mannitol, maltitol, xylitol, polydextrose, and isomalt).
Many studies and meta-analysis in adults have shown that a low FODMAPs diet is effective in reducing IBS symptoms, particularly bloating and abdominal pain. On the other hand, evidences in children are scarce.
Previous studies in adults have demonstrated differences in urine metabolites between IBS patients receiving LFD compared to a high FODMAP diet (HFD), providing interesting hypotheses for pathophysiological mechanisms in IBS.
Aim of this study is to evaluate the efficacy of a LFD on gastrointestinal symptoms in children with IBS. Moreover, the investigators will assess the impact of LFD vs a diet with a standard content of FODMAPs (SFD) on the fecal and urinary metabolomic profile of pediatric IBS patients.
This is a single center, prospective, single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari.
The trial includes four phases (run-in, low FODMAP diet, wash out and standard FODMAP diet). The run-in phase (weeks 1-2) aim to assess basal symptoms while on habitual diet and only symptomatic children (VAS\>3) will progress to the dietetic intervention trial.
Then patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet.
Detailed description
Single center, prospective, single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari Metabolomic analysis will be performed at Department of Soil, Plant and Food Science, University of Bari Aldo Moro.
The study will include all consecutive patients diagnosed with IBS according to the Rome IV criteria at Giovanni XXII Children's Hospital of Bari. The Giovanni XXII Children's Hospital of Bari is the tertiary referral center for the diagnosis and follow-up of gastrointestinal disorders in our region, covering an estimated population of 1400000 children, (National Institute of Statistics-https://www.istat.it accessed on 1 January 2023) with more than 10000 children followed up in the gastrointestinal clinic.
The trial includes four phases (run-in, low FODMAP diet, wash out and standard FODMAP diet). The run-in phase (weeks 1-2) aim to assess basal symptoms while on habitual diet and only symptomatic children (VAS\>3) will progress to the dietetic intervention trial.
Then patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet. The order of the dietetic regimens is established according a computer-generated randomization list.
Fecal and urinary samples for analyzing metabolome will be collected before interventions and at the end of each dietetic regimen.
The study adheres to the Declaration of Helsinki, was approved by the institutional ethical committee. All patients gave full written informed consent.
Dietetic intervention An experienced dietician will design two different dietetic regimens (SFD and LFD), as a tailored personalized menu of 2 weeks duration, with manual calculation of nutrients and kilocalories according child age and weight. At enrollment the dietician will explain the diets in detail to the families who will be not aware of the content of FODMAP (low vs. standard). Parents will be only advised that the purpose of the study is to "Assess whether changing the amount of certain foods in the diet could affects symptoms of IBS" and the concept of FODMAPs wont be never mentioned during the study. Both menus will be normocaloric and balanced in macro- and micronutrients in relation to the age of the patient under study, according to the main principles of the Mediterranean diet. All menus comprise five meals during the day: breakfast, snack, lunch, snack and dinner. Food options present in the menus will be agree between the dietician, parents and children.
The food intake will be recorded on a diary and the same dietician, during follow-up visits checked dietary compliance. A proper dietary adherence was defined if percentage of amount of food left was less than 10% and number of times non-compliant per week was less than 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single center, prospective, single blind low versus standard FODMAPs diet trial with crossover
| Arm | Type | Receives |
|---|---|---|
| LOW FODMAP-wash out- STANDARD FODMAPs | Active comparator | Other: LOW FODMAPs DietArm starting with low fodmap diet |
| STANDARD FODMAPs-wash out-LOW FODMAP | Active comparator | Other: LOW FODMAPs DietArm starting with standard fodmap diet |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age between 4 and 18 years; b) diagnosis of IBS according to Rome IV criteria; c) absence of other organic diseases; d) feeding via the oral route; e) ability to read and comprehend any employed questionnaires/scales; f) signed informed consent;
Key exclusion criteria (1 listed)
- organic disease b)some other FGID (not IBS) or lactose intolerance c) having already followed an exclusion diet d)in case of pregnancy e)eating disorders f) prior surgery of the gastrointestinal tract g) neurodevelopmental disabilities
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 |
|---|---|---|
| LOW FODMAPs DietAlso: STANDARD FODMAPs Dietpatients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms started the wash-out period of two weeks and subsequently started the final 2-week period on standard or low FODMAP diet. The LFD will have a FODMAP content expressed in grams 0.15 g/kg/d FODMAPs (maximum 10 g/day) while the SFD will contain 0.7 g/kg/d FODMAPs (maximum 60 g/day). | Other | LOW FODMAP-wash out- STANDARD FODMAPs, STANDARD FODMAPs-wash out-LOW FODMAP |
Primary outcome
Visual Analogue Scale
Time frame: from running in and during all the dietetic treatment
0-10
Irritable bowel Syndrome-Severity score
Time frame: 15 days
Is a five-item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life, scoring from 0 to 500. Cut-off of to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS
1 secondary outcome
Fecal and urinary Metabolome
Time frame: 14 days
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 9 Feb 2026.
- Results publication: PubMed 36364888Caponio GR, Celano G, Calabrese FM, Riezzo G, Orlando A, D'Attoma B, Ignazzi A, Vacca M, Porrelli A, Tutino V, De Angelis M, Giannelli G, Russo F. Evaluation of the Effects of the Tritordeum-Based Diet Compared to the Low-FODMAPs Diet on the Fecal Metabolome of IBS-D Patients: A Preliminary Investigation. Nutrients. 2022 Nov 2;14(21):4628. doi: 10.3390/nu14214628.
- Results publication: PubMed 25016597Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.
- Results publication: PubMed 28625832Staudacher HM, Lomer MCE, Farquharson FM, Louis P, Fava F, Franciosi E, Scholz M, Tuohy KM, Lindsay JO, Irving PM, Whelan K. A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial. Gastroenterology. 2017 Oct;153(4):936-947. doi: 10.1053/j.gastro.2017.06.010. Epub 2017 Jun 15.
- Results publication: PubMed 27144632Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
- Derived from this study: PubMed 42124549Cristofori F, Celano G, Dargenio VN, Apa CA, Amendolara M, Stella M, Castellaneta S, Barone M, Vacca M, De Angelis M, Francavilla R. Clinical trial: Efficacy of a Low FODMAP Diet in Paediatric Irritable Bowel Syndrome-A Randomised Crossover Trial With Exploratory Metabolomic Analysis. Aliment Pharmacol Ther. 2026 Jun;63(12):1592-1604. doi: 10.1111/apt.70718. Epub 2026 May 13.
- Individual participant dataSharing planned: Yes. Study Protocol and CSR will be available on request via email (fernandacristofori@gmail.com)
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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.
Ruggiero Francavilla, Prof principal investigator
Interdisciplinary department of Medicine Pediatric section. University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOW FODMAPs Diet in people with IBS and Functional Gastrointestinal Disorders, run by University of Bari at 1 site 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 1 inclusion and 1 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Visual Analogue Scale (time frame: from running in and during all the dietetic treatment). The study lists 2 primary outcomes in all. 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 NCT06618677, which also lists 5 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 9 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.