Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects

Conditions
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IBS - Irritable Bowel Syndrome, Inflammation

Intervention / Treatment
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* Behavioral: Rotation Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IBS (according to ROME IV criteria) blood analysis within 1yr with CBC, TSHr, ESR, CRP, urine, glucose attitude to change dietary habits willing to follow study protocol Exclusion Criteria: low BMI (<18.5 kg/m2) pregnancy restrictive dietary habits (e.g. veganism) positive FOBT faecal calprotectin >200 mcg/g known or recurrent bowel infections known or recurrent UTI (>3/yr) former diverticulitis alcohol abuse major concurrent disease (e.g. IBD, coeliac disease, eating disorder,...) pharmacological treatment with drugs that alter intestinal motility (e.g. PPI, metformin,...)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week | Behavioral: Rotation Diet<br>* Based on the food-specific IgG measurement and relative distribution, a personalized food profile was created for each subject identifying 1 to 3 relevant food groups/nutritional clusters. Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week. No calorie restriction was imposed in the diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BAFF levels | reduction of BAFF levels from baseline | 6 weeks | 
| PAF levels | reduction of PAF levels from baseline | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS symptom severity | IBS symptom severity score reduction from baseline | 6 weeks | 
| BMI | BMI reduction from baseline | 6 weeks |