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

Not Applicable

Recruiting

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Probiotic, Prebiotic; Other: Placebo; Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts

• Registration Number: NCT05990764
• Lead Sponsor: AronPharma Sp. z o. o.

Brief Summary

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.

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 Timeline

• Study Start: 2023-05-08
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic, Prebiotic	Probiotic, Prebiotic	18 patients with IBS
Placebo	Placebo	18 patients with IBS
Probiotic, Prebiotic, Polyphenol-rich Extracts	Probiotic, Prebiotic, Polyphenol-rich Extracts	18 patients with IBS

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
I-FABP	Baseline, 2 months	I-FABP level in serum samples
IL-6	Baseline, 2 months	IL-6 level in serum samples
Zonulin	Baseline, 2 months	Zonulin level in stool samples
Short-chain fatty acids	Baseline, 2 months	Short-chain fatty acids level in stool samples
IL-8	Baseline, 2 months	IL-8 level in serum samples

Trial Locations

Locations (1)

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu; 🇵🇱 Poznań, Poland