Clinical trial NCT04348760: Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
Official title: Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Inflammation
Lead sponsor: GEK Srl
Sponsor class: INDUSTRY
Collaborators: name: Hippocrates Research
First posted: 2020-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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,...)

Primary outcomes:
measure: BAFF levels
timeFrame: 6 weeks
measure: PAF levels
timeFrame: 6 weeks
Secondary outcomes:
measure: IBS symptom severity
timeFrame: 6 weeks
measure: BMI
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Milano
country: Italy
facility: GEK srl
Study officials:
affiliation: GEK Srl
name: Emiliana Tognon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SMA srl
name: Mattia Cappelletti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GEK Srl
name: Attilio F Speciani, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
citation: 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.