Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05738343
• Other study ID #: CE 6885/2022
• Status: Not yet recruiting
• Start date: February 20, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: February 2023
• Source: University of Roma La Sapienza
• Contact: Giulia Muzi
• Phone: +393289343322
• Email: giulia25muzi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 Participants will be visited, blood samples will be taken, abdomen ultrasound and they will answer questionnaires.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Other:
• dieta mediterranea
nutritional education or Mediterranean food scheme

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pediatric patients with IBS adherence to the Mediterranean diet	adherent patients on enrolled patients	Day 0
Secondary	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	Day 7