Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)

AronPharma Sp. z o. o.48 enrolled

Overview

The aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of IBS patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.

The double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

IBS - Irritable Bowel Syndrome

Interventions

Probiotic, Prebiotic, Polyphenol-rich ExtractsDIETARY_SUPPLEMENT

probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract Once a day

Probiotic, PrebioticDIETARY_SUPPLEMENT

probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) Once a day

PlaceboOTHER

placebo Once a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed Irritable Bowel Syndrome. * Women and men, 18-55 years old. * Signed informed consent. Exclusion Criteria: * Intake of supplements containing plant extracts, polyphenols or anthocyanins, and supplements containing fiber, probiotics and prebiotics. * Participation in another clinical trial. * Inability to swallow an oral study drug/placebo. * Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study. * Women who are pregnant, planning to become pregnant during the study, or breastfeeding,

Locations (1)

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland

RECRUITING