Irritable Bowel SyndromeNCT05738343
Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici
An observational study of Irritable Bowel Syndrome, run by University of Roma La Sapienza.
Trial summary
The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). The main question it aims to answer are: adherence to the Mediterranean diet of children with IBS in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention… Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- dieta mediterranea
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 20 Feb 2024
- Phase
- Observational
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients belonging to the Sant'Andrea hospital pediatric gastroenterology clinic, in Rome.
Who may be able to join
- diagnosis of IBS, based on Rome IV criteria.
Who cannot join
- use of NSAIDs in the last 3 months;
- allergies or intolerances;
- recent diagnosis (last 3 months) of bacterial or parasitic infections of the gastrointestinal tract;
- psychiatric diseases;
- chronic inflammatory diseases of the gastrointestinal tract.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adesione Alla Dieta Mediterranea Dei Pazienti Pediatrici Affetti Dalla Sindrome Dell'Intestino Irritabile (IBS): Studio Pilota
The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). The main question it aims to answer are:
- adherence to the Mediterranean diet of children with IBS
- in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention Participants will be visited, blood samples will be taken, abdomen ultrasound and they will answer questionnaires.
Read the detailed description
The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). the diagnosis of IBS will be placed in reference to the Rome IV criteria. To make a diagnosis, at least 2 of:
- abdominal pain for at least 4 days per month associated with one or more of: pain associated with bowel movements, change in bowel frequency, change in stool consistency must be present.
- In children with constipation, pain persists as the constipation resolves.
- The symptoms are not explained by another medical condition. Participants will be visited, blood samples will be taken, abdomen ultrasound if necessary will be performed and they will answer questionnaires.
The main question it aims to answer are:
- adherence to the Mediterranean diet of children with IBS
- in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention. if BMI between 5 and 85, nutritional education will be carried out for a healthy and correct diet. If BMI between 85 and 95 or greater than 95, personalized Mediterranean food scheme.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- dieta mediterranea
- Keywords
- irritable bowel syndrome, pediatric, mediterranean diet, childhood, ibs, treatment
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dieta mediterraneaOther
Also called mediterranean diet
nutritional education or Mediterranean food scheme
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric patients with IBS adherence to the Mediterranean diet
adherent patients on enrolled patients
Measured: Day 0
Secondary outcomes (1)
How many pediatric IBS patients who do not adhere to the Mediterranean diet, respond to nutritional intervention?
Pediatric IBS patients who do not adhere to the Mediterranean diet will be instructed in a correct diet according to the Mediterranean diet or they will have a personalized diet and then the Rome IV criteria will be re-evaluated
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Di Nardo, University of Roma La Sapienza
- Investigators
- Giovanni Di Nardo, Principal investigator, Sapienza, Università di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738343
- Sponsor's protocol ID
- CE 6885/2022
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211.
PubMed 29881232Cassar GE, Youssef J G, Knowles SR, Moulding R, Austin D. The Impact of Diagnostic Status on Quality of Life in Irritable Bowel Syndrome. Turk J Gastroenterol. 2021 Oct;32(10):808-818. doi: 10.5152/tjg.2021.20517.
PubMed 34787085Hyams 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 27144632Saps M, Miranda A. Gastrointestinal Pharmacology. Handb Exp Pharmacol. 2017;239:147-176. doi: 10.1007/164_2016_119.
PubMed 28236087Saps M, Biring HS, Pusatcioglu CK, Mintjens S, Rzeznikiewiz D. A comprehensive review of randomized placebo-controlled pharmacological clinical trials in children with functional abdominal pain disorders. J Pediatr Gastroenterol Nutr. 2015 May;60(5):645-53. doi: 10.1097/MPG.0000000000000718.
PubMed 25906454Bhesania N, Cresci GAM. A nutritional approach for managing irritable bowel syndrome. Curr Opin Pediatr. 2017 Oct;29(5):584-591. doi: 10.1097/MOP.0000000000000536.
PubMed 28737582Paduano D, Cingolani A, Tanda E, Usai P. Effect of Three Diets (Low-FODMAP, Gluten-free and Balanced) on Irritable Bowel Syndrome Symptoms and Health-Related Quality of Life. Nutrients. 2019 Jul 11;11(7):1566. doi: 10.3390/nu11071566.
PubMed 31336747Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12.
PubMed 28254269Manzano-Carrasco S, Felipe JL, Sanchez-Sanchez J, Hernandez-Martin A, Gallardo L, Garcia-Unanue J. Weight Status, Adherence to the Mediterranean Diet, and Physical Fitness in Spanish Children and Adolescents: The Active Health Study. Nutrients. 2020 Jun 4;12(6):1680. doi: 10.3390/nu12061680.
PubMed 32512886Serra-Majem L, Tomaino L, Dernini S, Berry EM, Lairon D, Ngo de la Cruz J, Bach-Faig A, Donini LM, Medina FX, Belahsen R, Piscopo S, Capone R, Aranceta-Bartrina J, La Vecchia C, Trichopoulou A. Updating the Mediterranean Diet Pyramid towards Sustainability: Focus on Environmental Concerns. Int J Environ Res Public Health. 2020 Nov 25;17(23):8758. doi: 10.3390/ijerph17238758.
PubMed 33255721Mannocci A, Di Thiene D, Del Cimmuto A, Masala D, Boccia A, De Vito E, La Torre G. International Physical Activity Questionnaire: validation and assessment in an Italian sample. Ital J Public Health 2010; 7(4):369-76.
Veiga OL, Gomez-Martinez S, Martinez-Gomez D, Villagra A, Calle ME, Marcos A; AFINOS Study Group. Physical activity as a preventive measure against overweight, obesity, infections, allergies and cardiovascular disease risk factors in adolescents: AFINOS Study protocol. BMC Public Health. 2009 Dec 19;9:475. doi: 10.1186/1471-2458-9-475.
PubMed 20021690Zanini B, Simonetto A, Bertolotti P, Marullo M, Marconi S, Becchetti C, Gilioli G, Valerio A, Donato F, Ricci C, Castellano M. A new self-administered semi-quantitative food frequency questionnaire to estimate nutrient intake among Italian adults: development design and validation process. Nutr Res. 2020 Aug;80:18-27. doi: 10.1016/j.nutres.2020.05.008. Epub 2020 May 19.
PubMed 32673962Archero F, Ricotti R, Solito A, Carrera D, Civello F, Di Bella R, Bellone S, Prodam F. Adherence to the Mediterranean Diet among School Children and Adolescents Living in Northern Italy and Unhealthy Food Behaviors Associated to Overweight. Nutrients. 2018 Sep 18;10(9):1322. doi: 10.3390/nu10091322.
PubMed 30231531Bonaccorsi G, Furlan F, Scocuzza M, Lorini C. Adherence to Mediterranean Diet among Students from Primary and Middle School in the Province of Taranto, 2016-2018. Int J Environ Res Public Health. 2020 Jul 28;17(15):5437. doi: 10.3390/ijerph17155437.
PubMed 32731568
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adesione Alla Dieta Mediterranea Dei Pazienti Pediatrici Affetti Dalla Sindrome Dell'Intestino Irritabile (IBS): Studio Pilota
- ClinicalTrials.gov ID
- NCT05738343
- Acronym / sponsor ID
- CE 6885/2022
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, pediatric, mediterranean diet, childhood, ibs, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 22 Feb 2023 (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 observational study is to observe pediatric patients with IBS (irritable bowel syndrome). The main question it aims to answer are:
- adherence to the Mediterranean diet of children with IBS
- in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention Participants will be visited, blood samples will be taken, abdomen ultrasound and they will answer questionnaires.
Detailed description
The goal of this observational study is to observe pediatric patients with IBS (irritable bowel syndrome). the diagnosis of IBS will be placed in reference to the Rome IV criteria. To make a diagnosis, at least 2 of:
- abdominal pain for at least 4 days per month associated with one or more of: pain associated with bowel movements, change in bowel frequency, change in stool consistency must be present.
- In children with constipation, pain persists as the constipation resolves.
- The symptoms are not explained by another medical condition. Participants will be visited, blood samples will be taken, abdomen ultrasound if necessary will be performed and they will answer questionnaires.
The main question it aims to answer are:
- adherence to the Mediterranean diet of children with IBS
- in patients not adhering to the Mediterranean diet, evaluate the efficacy of the nutritional intervention. if BMI between 5 and 85, nutritional education will be carried out for a healthy and correct diet. If BMI between 85 and 95 or greater than 95, personalized Mediterranean food scheme.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients belonging to the Sant'Andrea hospital pediatric gastroenterology clinic, in Rome.
Key inclusion criteria (1 listed)
- diagnosis of IBS, based on Rome IV criteria.
Key exclusion criteria (5 listed)
- use of NSAIDs in the last 3 months;
- allergies or intolerances;
- recent diagnosis (last 3 months) of bacterial or parasitic infections of the gastrointestinal tract;
- psychiatric diseases;
- chronic inflammatory diseases of the gastrointestinal tract.
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 |
|---|---|---|
| dieta mediterraneaAlso: mediterranean dietnutritional education or Mediterranean food scheme | Other | – |
Primary outcome
pediatric patients with IBS adherence to the Mediterranean diet
Time frame: Day 0
adherent patients on enrolled patients
1 secondary outcome
How many pediatric IBS patients who do not adhere to the Mediterranean diet, respond to nutritional intervention?
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 29881232Devanarayana NM, Rajindrajith S. Irritable bowel syndrome in children: Current knowledge, challenges and opportunities. World J Gastroenterol. 2018 Jun 7;24(21):2211-2235. doi: 10.3748/wjg.v24.i21.2211.
- Background: PubMed 34787085Cassar GE, Youssef J G, Knowles SR, Moulding R, Austin D. The Impact of Diagnostic Status on Quality of Life in Irritable Bowel Syndrome. Turk J Gastroenterol. 2021 Oct;32(10):808-818. doi: 10.5152/tjg.2021.20517.
- Background: 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.
- Background: PubMed 28236087Saps M, Miranda A. Gastrointestinal Pharmacology. Handb Exp Pharmacol. 2017;239:147-176. doi: 10.1007/164_2016_119.
- Background: PubMed 25906454Saps M, Biring HS, Pusatcioglu CK, Mintjens S, Rzeznikiewiz D. A comprehensive review of randomized placebo-controlled pharmacological clinical trials in children with functional abdominal pain disorders. J Pediatr Gastroenterol Nutr. 2015 May;60(5):645-53. doi: 10.1097/MPG.0000000000000718.
- Background: PubMed 28737582Bhesania N, Cresci GAM. A nutritional approach for managing irritable bowel syndrome. Curr Opin Pediatr. 2017 Oct;29(5):584-591. doi: 10.1097/MOP.0000000000000536.
- Background: PubMed 31336747Paduano D, Cingolani A, Tanda E, Usai P. Effect of Three Diets (Low-FODMAP, Gluten-free and Balanced) on Irritable Bowel Syndrome Symptoms and Health-Related Quality of Life. Nutrients. 2019 Jul 11;11(7):1566. doi: 10.3390/nu11071566.
- Background: PubMed 28254269Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12.
- Background: PubMed 32512886Manzano-Carrasco S, Felipe JL, Sanchez-Sanchez J, Hernandez-Martin A, Gallardo L, Garcia-Unanue J. Weight Status, Adherence to the Mediterranean Diet, and Physical Fitness in Spanish Children and Adolescents: The Active Health Study. Nutrients. 2020 Jun 4;12(6):1680. doi: 10.3390/nu12061680.
- Background: PubMed 33255721Serra-Majem L, Tomaino L, Dernini S, Berry EM, Lairon D, Ngo de la Cruz J, Bach-Faig A, Donini LM, Medina FX, Belahsen R, Piscopo S, Capone R, Aranceta-Bartrina J, La Vecchia C, Trichopoulou A. Updating the Mediterranean Diet Pyramid towards Sustainability: Focus on Environmental Concerns. Int J Environ Res Public Health. 2020 Nov 25;17(23):8758. doi: 10.3390/ijerph17238758.
- BackgroundMannocci A, Di Thiene D, Del Cimmuto A, Masala D, Boccia A, De Vito E, La Torre G. International Physical Activity Questionnaire: validation and assessment in an Italian sample. Ital J Public Health 2010; 7(4):369-76.
- Background: PubMed 20021690Veiga OL, Gomez-Martinez S, Martinez-Gomez D, Villagra A, Calle ME, Marcos A; AFINOS Study Group. Physical activity as a preventive measure against overweight, obesity, infections, allergies and cardiovascular disease risk factors in adolescents: AFINOS Study protocol. BMC Public Health. 2009 Dec 19;9:475. doi: 10.1186/1471-2458-9-475.
- Individual participant dataSharing planned: No
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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.
Giovanni Di Nardo principal investigator
Sapienza, Università di Roma
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by University of Roma La Sapienza.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Muzi (+393289343322, giulia25muzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pediatric patients with IBS adherence to the Mediterranean diet (time frame: Day 0). 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 NCT05738343, which also lists 29 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 22 Feb 2023.