Status:
UNKNOWN
Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Lead Sponsor:
AronPharma Sp. z o. o.
Conditions:
IBS - Irritable Bowel Syndrome
Eligibility:
All Genders
18-55 years
Phase:
NA
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 int...
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 wit...
Eligibility Criteria
Inclusion
- Diagnosed Irritable Bowel Syndrome.
- Women and men, 18-55 years old.
- Signed informed consent.
Exclusion
- 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,
Key Trial Info
Start Date :
May 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05990764
Start Date
May 8 2023
End Date
January 31 2024
Last Update
November 18 2023
Active Locations (1)
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1
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland