Inflammation Clinical Trial
Official title:
Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects
Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life. Despite the prevalence of IBS, its etiology and pathophysiology are still to be fully understood, but immune response is known to be involved. In this study, the investigators researched the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS), following a personalized an unrestricted-calorie diet.
The investigators enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria,
whose inflammatory markers were measured at baseline and after 6 weeks of dietary
intervention. The subjects were monitored in a general practice outpatient setting (GP) and
nutritional advice was offered remotely via two telephone sessions with a nutritionist. The
researchers investigated the variation of two specific cytokines, B-cell activating factor
(BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom
severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS).
Data monitoring was ensured by an external monitor (Hippocrates Research, Genova, Italy).
All data entry was in accordance with GCP protocol, and AE were classified using CTCAE 4.0
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