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Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici

U

University of Roma La Sapienza

Status

Not yet enrolling

Conditions

Irritable Bowel Syndrome

Treatments

Other: dieta mediterranea

Study type

Observational

Funder types

Other

Identifiers

NCT05738343
CE 6885/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

4 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

0

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Central trial contact

Giulia Muzi

Data sourced from clinicaltrials.gov

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