NCT04348760

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

Completed NA Last updated 17 April 2020

What this trial tests

NA trial testing Rotation Diet in IBS - Irritable Bowel Syndrome in 30 participants. Completed in 30 July 2019.

Timeline

1 May 2019

Primary endpoint
30 July 2019

30 July 2019

Quick facts

Lead sponsor	GEK Srl
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 May 2019
Primary completion	30 July 2019
Estimated completion	30 July 2019
Sites	1 location across Italy

Drugs / interventions tested

• Rotation Diet

Conditions studied

• IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →
• Inflammation — all drugs for Inflammation →

Sponsor

GEK Srl

Who can join

Adults 18 to 50, any sex, with IBS - Irritable Bowel Syndrome or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Food-specific serum IgG and symptom reduction with a personalized, unrestricted-calorie diet of six weeks in Irritable Bowel Syndrome (IBS).
   Cappelletti M, Tognon E, Vona L, Basello K, et al · · 2020 · cited 8× · PMID 33292297 · DOI 10.1186/s12986-020-00528-x