Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici

NCT05738343 | Unknown

• 1 other identifier: CE 6885/2022
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• pediatric patients with IBS adherence to the Mediterranean diet

  adherent patients on enrolled patients

  Day 0

Secondary Outcomes (1)

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

  Day 7

Interventions

dieta mediterranea OTHER

nutritional education or Mediterranean food scheme

Also known as: mediterranean diet

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients belonging to the Sant'Andrea hospital pediatric gastroenterology clinic, in Rome.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (29)

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MeSH Terms

Conditions

Irritable Bowel Syndrome; Ichthyosis Bullosa of Siemens

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Giovanni Di Nardo

  Sapienza, Università di Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Muzi

CONTACT

+393289343322; giulia25muzi@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 22, 2023
• Study Start: February 20, 2023
• Primary Completion: January 20, 2024
• Study Completion: February 20, 2024
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share