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

NCT04348760 | Completed DMC

• 1 other identifier: 2019_01_IBS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome; Inflammation

Outcome Measures

Primary Outcomes (2)

• BAFF levels

  reduction of BAFF levels from baseline

  6 weeks

• PAF levels

  reduction of PAF levels from baseline

  6 weeks

Secondary Outcomes (2)

• IBS symptom severity

  6 weeks

• BMI

  6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Rotation Diet BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,...)

Sponsors & Collaborators

• GEK Srl: lead
• Hippocrates Research: collaborator

Study Sites (1)

GEK srl

Milan, 20149, Italy

Location

Related Publications (4)

• 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.

  PMID: 30288077 BACKGROUND

• 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.

  PMID: 20353497 BACKGROUND

• 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.

  PMID: 23170971 BACKGROUND

• 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.

  PMID: 33292297 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emiliana Tognon, PhD

  GEK Srl

  PRINCIPAL INVESTIGATOR

• Mattia Cappelletti, MD

  SMA srl

  PRINCIPAL INVESTIGATOR

• Attilio F Speciani, MD

  GEK Srl

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: May 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: immediately following and for 36 months after publication
• Access Criteria: Proposals should be directed to the PI/Sponsor. To gain access, data requestors will need to sign a data access agreement

Locations

IT (1)