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

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome; Inflammation

• Registration Number: NCT04348760
• Lead Sponsor: GEK Srl

Brief Summary

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

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

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-15
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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,...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
BAFF levels	6 weeks	reduction of BAFF levels from baseline
PAF levels	6 weeks	reduction of PAF levels from baseline

Secondary Outcome Measures

Name	Time	Method
IBS symptom severity	6 weeks	IBS symptom severity score reduction from baseline
BMI	6 weeks	BMI reduction from baseline

Trial Locations

Locations (1)

GEK srl; 🇮🇹 Milano, Italy