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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2024-01-31

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.

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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.

Conditions

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IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Probiotic, Prebiotic, Polyphenol-rich Extracts

18 patients with IBS

Group Type EXPERIMENTAL

Probiotic, Prebiotic, Polyphenol-rich Extracts

Intervention Type DIETARY_SUPPLEMENT

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

Once a day

Probiotic, Prebiotic

18 patients with IBS

Group Type EXPERIMENTAL

Probiotic, Prebiotic

Intervention Type DIETARY_SUPPLEMENT

probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)

Once a day

Placebo

18 patients with IBS

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo

Once a day

Interventions

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Probiotic, Prebiotic, Polyphenol-rich Extracts

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

Once a day

Intervention Type DIETARY_SUPPLEMENT

Probiotic, Prebiotic

probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)

Once a day

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo

Once a day

Intervention Type OTHER

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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No