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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Rotation 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20149
    • GEK srl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GEK Srl
• Collaborators: Hippocrates Research
• Investigators: Principal Investigator: Emiliana Tognon, PhD, GEK srl; Principal Investigator: Mattia Cappelletti, MD, SMA srl; Study Director: Attilio F Speciani, MD, GEK srl

Publications and helpful links

General Publications

• Ng QX, Soh AYS, Loke W, Lim DY, Yeo WS. The role of inflammation in irritable bowel syndrome (IBS). J Inflamm Res. 2018 Sep 21;11:345-349. doi: 10.2147/JIR.S174982. eCollection 2018.
• Lied GA, Lillestol K, Valeur J, Berstad A. Intestinal B cell-activating factor: an indicator of non-IgE-mediated hypersensitivity reactions to food? Aliment Pharmacol Ther. 2010 Jul;32(1):66-73. doi: 10.1111/j.1365-2036.2010.04314.x. Epub 2010 Mar 26.
• Ligaarden SC, Lydersen S, Farup PG. IgG and IgG4 antibodies in subjects with irritable bowel syndrome: a case control study in the general population. BMC Gastroenterol. 2012 Nov 21;12:166. doi: 10.1186/1471-230X-12-166.
• Cappelletti M, Tognon E, Vona L, Basello K, Costanzi A, Speciani MC, Speciani AF. Food-specific serum IgG and symptom reduction with a personalized, unrestricted-calorie diet of six weeks in Irritable Bowel Syndrome (IBS). Nutr Metab (Lond). 2020 Dec 1;17(1):101. doi: 10.1186/s12986-020-00528-x.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Inflammation; Irritable Bowel Syndrome
• Other Study ID Numbers: 2019_01_IBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participants data that underline the results reported in article, after deidentification (text, tables)
• IPD Sharing Time Frame: immediately following and for 36 months after publication
• IPD Sharing Access Criteria: Proposals should be directed to the PI/Sponsor. To gain access, data requestors will need to sign a data access agreement
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No