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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05990764

Enrollment

Registered

2023-08-14

Start date

2023-05-08

Completion date

2024-01-31

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome

Keywords

IBS, Gastrointestinal diseases, Probiotic, Prebiotic, Plant extract, Polyphenol-rich Extracts

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.

Interventions

DIETARY_SUPPLEMENTProbiotic, Prebiotic, Polyphenol-rich Extracts

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

DIETARY_SUPPLEMENTProbiotic, Prebiotic

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

OTHERPlacebo

placebo Once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026