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

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990764
• Other study ID #: 03-AP-IBS
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: AronPharma Sp. z o. o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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,

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Probiotic, Prebiotic, Polyphenol-rich Extracts
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract Once a day
• Probiotic, Prebiotic
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) Once a day

Other:
• Placebo
placebo Once a day

Locations

Country	Name	City	State
Poland	Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
AronPharma Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stool consistency	Will be assessed using the Bristol Stool Chart	Baseline, 2 months
Secondary	Zonulin	Zonulin level in stool samples	Baseline, 2 months
Secondary	Short-chain fatty acids	Short-chain fatty acids level in stool samples	Baseline, 2 months
Secondary	IL-6	IL-6 level in serum samples	Baseline, 2 months
Secondary	IL-8	IL-8 level in serum samples	Baseline, 2 months
Secondary	I-FABP	I-FABP level in serum samples	Baseline, 2 months