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Clinical Trials/NCT05738343
NCT05738343
Not yet recruiting
Not Applicable

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

University of Roma La Sapienza0 sites50 target enrollmentFebruary 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
University of Roma La Sapienza
Enrollment
50
Primary Endpoint
pediatric patients with IBS adherence to the Mediterranean diet
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2023
End Date
February 20, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Prof. Giovanni Di Nardo

Professor

University of Roma La Sapienza

Eligibility Criteria

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.

Outcomes

Primary Outcomes

pediatric patients with IBS adherence to the Mediterranean diet

Time Frame: Day 0

adherent patients on enrolled patients

Secondary Outcomes

  • How many pediatric IBS patients who do not adhere to the Mediterranean diet, respond to nutritional intervention?(Day 7)

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