Dieta Mediterranea e Sindrome Dell'Intestino Irritabile in Pazienti Pediatrici
NCT ID: NCT05738343
Last Updated: 2023-02-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-02-20
Study Completion Date
2024-02-20
Brief Summary
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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.
* 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.
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Detailed Description
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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.
* 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.
Conditions
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Irritable Bowel Syndrome
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Interventions
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dieta mediterranea
nutritional education or Mediterranean food scheme
Intervention Type
OTHER
Other Intervention Names
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mediterranean diet
Eligibility Criteria
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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.
* 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.
Minimum Eligible Age
4 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Roma La Sapienza
OTHER
Sponsor Role
lead
Responsible Party
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Prof. Giovanni Di Nardo
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Giovanni Di Nardo
Role: PRINCIPAL_INVESTIGATOR
Sapienza, Università di Roma
Central Contacts
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References
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Reference Type
RESULT
Other Identifiers
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CE 6885/2022
Identifier Type: -
Identifier Source: org_study_id
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