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

AronPharma

Status: Enrolling

Conditions: IBS - Irritable Bowel Syndrome

Treatments: Dietary Supplement: Probiotic, Prebiotic; Other: Placebo; Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts

Study type: Interventional

Funder types: Industry

Identifiers

NCT05990764

03-AP-IBS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Probiotic, Prebiotic, Polyphenol-rich Extracts

Experimental group

Description:

18 patients with IBS

Treatment:

Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts

Probiotic, Prebiotic

Experimental group

Description:

18 patients with IBS

Treatment:

Dietary Supplement: Probiotic, Prebiotic

Placebo

Placebo Comparator group

Description:

18 patients with IBS

Treatment:

Other: Placebo