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

GEK Srl

Status: Completed

Conditions: Inflammation; IBS - Irritable Bowel Syndrome

Treatments: Behavioral: Rotation Diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04348760

2019_01_IBS

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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,...)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Rotation Diet