Effects of a combination of polyphenol-rich extracts, prebiotics, and hydrolyzed fiber on the quality of life of patients with irritable bowel syndrome (IBS). (Commercial product – gastro line)
- Bioethics Committee Approval Number:
110/23 - NCT Number:
clinicaltrials.gov - Status:
study completed
The aim of the study is to determine and compare the effectiveness of selected combinations of active ingredients on troublesome symptoms related to IBS, including reducing intestinal inflammation, improving gut microbiota, and enhancing intestinal peristalsis. Irritable Bowel Syndrome (IBS) is a chronic gastrointestinal disorder that significantly lowers the quality of life. IBS is characterized by irregular bowel movements combined with abdominal discomfort or pain. It is estimated that this condition affects 9-23% of the general population [1]. Saccharomyces boulardii yeast has antidiarrheal and anti-inflammatory properties [2]. Selected bacterial strains colonize the large intestine and have probiotic properties (reducing abdominal pain, bloating, and frequency of bowel movements in IBS patients), while plant extracts rich in polyphenols exhibit antioxidant and anti-inflammatory potential [3]. The selected probiotic, a source of fiber, regulates bowel movements and has a beneficial effect on the overall functioning of the digestive system [4].
The study includes the following groups:
- receiving a placebo,
- receiving a combination of multi-strain probiotic bacteria, yeast, and prebiotic,
- receiving a comprehensive preparation (a combination of multi-strain probiotic bacteria, yeast, prebiotic, and Fenactive® mixture standardized for polyphenol and anthocyanin content).
The study group consists of adult patients diagnosed with Irritable Bowel Syndrome (IBS).
As part of the study, markers of inflammation and proper intestinal barrier function will be measured. Additionally, the IBS-QOL questionnaire will be administered to assess the symptoms and discomforts associated with IBS.
[1] Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014 Jun 14;20(22):6759-73.
[2] Kelesidis T, Pothoulakis C. Efficacy and safety of the probiotic Saccharomyces boulardii for theprevention and therapy of gastrointestinal disorders. Therap Adv Gastroenterol. 2012 Mar;5(2):111-25.
[3] Pratt C, Campbell MD. The Effect of Bifidobacterium on Reducing Symptomatic Abdominal Pain in Patients with Irritable Bowel Syndrome: A Systematic Review. Probiotics Antimicrob Proteins. 2020 Sep;12(3):834-839.
[4] So D, Gibson PR, Muir JG, Yao CK. Dietary fibres and IBS: translating functional characteristics to clinical value in the era of personalised medicine. Gut. 2021 Dec;70(12):2383-2394.