Irritable Bowel Syndrome Clinical Trial
Official title:
Adesione Alla Dieta Mediterranea Dei Pazienti Pediatrici Affetti Dalla Sindrome Dell'Intestino Irritabile (IBS): Studio Pilota
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Roma La Sapienza |
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* Note: There are 29 references in all — Click here to view all references
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 |
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