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

NCT05990764 | Unknown

• 1 other identifier: 03-AP-IBS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Zonulin

  Baseline, 2 months

• Short-chain fatty acids

  Baseline, 2 months

• IL-6

  Baseline, 2 months

• IL-8

  Baseline, 2 months

• I-FABP

  Baseline, 2 months

Study Arms (3)

Probiotic, Prebiotic, Polyphenol-rich Extracts

EXPERIMENTAL

18 patients with IBS

Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts

Probiotic, Prebiotic

EXPERIMENTAL

18 patients with IBS

Dietary Supplement: Probiotic, Prebiotic

Placebo

PLACEBO COMPARATOR

18 patients with IBS

Other: Placebo

Interventions

Probiotic, Prebiotic, Polyphenol-rich Extracts DIETARY_SUPPLEMENT

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

Probiotic, Prebiotic, Polyphenol-rich Extracts

Probiotic, Prebiotic DIETARY_SUPPLEMENT

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

Probiotic, Prebiotic

Placebo OTHER

placebo Once a day

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed Irritable Bowel Syndrome.
• Women and men, 18-55 years old.
• Signed informed consent.

You may not qualify if:

• 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,

Sponsors & Collaborators

• AronPharma Sp. z o. o.: lead

Study Sites (1)

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases

Interventions

Probiotics; Prebiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 14, 2023
• Study Start: May 8, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)