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

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.

Study Overview

• Status: Recruiting
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts; Dietary supplement: Probiotic, Prebiotic; Other: Placebo

Detailed Description

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
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland
    • Recruiting
    • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
    • Contact: Barbara Khaidakov, PhD; Phone Number: +48 798 210 651; Email: barbara.khaidakov@aronpharma.pl
    • Principal Investigator: Dorota Mańkowska-Wierzbicka, MD, PhD
    • Sub-Investigator: Liliana Łykowska-Szuber, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic, Prebiotic, Polyphenol-rich Extracts; 18 patients with IBS	Dietary supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts; probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract Once a day
Experimental: Probiotic, Prebiotic; 18 patients with IBS	Dietary supplement: Probiotic, Prebiotic; probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) Once a day
Placebo Comparator: Placebo; 18 patients with IBS	Other: Placebo; placebo Once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index	IBS-QoL measures the impact of the disease on the quality of life of patients with IBS	Baseline, 2 months
Stool consistency	Will be assessed using the Bristol Stool Chart	Baseline, 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zonulin	Zonulin level in stool samples	Baseline, 2 months
Short-chain fatty acids	Short-chain fatty acids level in stool samples	Baseline, 2 months
IL-6	IL-6 level in serum samples	Baseline, 2 months
IL-8	IL-8 level in serum samples	Baseline, 2 months
I-FABP	I-FABP level in serum samples	Baseline, 2 months

Collaborators and Investigators

• Sponsor: AronPharma Sp. z o. o.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: IBS; Prebiotic; Probiotic; Gastrointestinal diseases; Plant extract; Polyphenol-rich Extracts
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 03-AP-IBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No