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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts
* Dietary Supplement: Probiotic, Prebiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Gastrointestinal diseases, Probiotic, Prebiotic, Plant extract, Polyphenol-rich Extracts