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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348760
• Other study ID #: 2019_01_IBS
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: April 2020
• Source: GEK Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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,...)

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Inflammation
• Irritable Bowel Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	GEK srl	Milano

Sponsors (2)

Lead Sponsor	Collaborator
GEK Srl	Hippocrates Research

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Lied GA, Lillestøl 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BAFF levels	reduction of BAFF levels from baseline	6 weeks
Primary	PAF levels	reduction of PAF levels from baseline	6 weeks
Secondary	IBS symptom severity	IBS symptom severity score reduction from baseline	6 weeks
Secondary	BMI	BMI reduction from baseline	6 weeks