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Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici

Adesione Alla Dieta Mediterranea Dei Pazienti Pediatrici Affetti Dalla Sindrome Dell'Intestino Irritabile (IBS): Studio Pilota

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05738343
Enrollment
50
Registered
2023-02-22
Start date
2023-02-20
Completion date
2024-02-20
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome, pediatric, mediterranean diet, childhood, ibs, treatment

Brief 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 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.

Interventions

OTHERdieta mediterranea

nutritional education or Mediterranean food scheme

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

\- diagnosis of IBS, based on Rome IV criteria.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
pediatric patients with IBS adherence to the Mediterranean dietDay 0adherent patients on enrolled patients

Secondary

MeasureTime frameDescription
How many pediatric IBS patients who do not adhere to the Mediterranean diet, respond to nutritional intervention?Day 7Pediatric 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

Contacts

Primary ContactGiulia Muzi
giulia25muzi@gmail.com+393289343322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026