Effects of a Polyphenol-Rich Extract Blend, Probiotics, and Hydrolyzed Fiber on Quality of Life and Gut Health Markers in Patients with Irritable Bowel Syndrome -a Randomized, Double-Blind, Placebo-Controlled Trial

Adrianna Wierzbicka^1,2Barbara Khaidakov³Oliwia Zakerska-Banaszak⁴Paulina Andrzejewska³Alina Baturo¹Paulina Kowalczyk⁵Krzysztof Lemke³Agnieszka Dobrowolska¹Marzena Skrzypczak-Zielinska⁴Dorota Mańkowska-Wierzbicka^1*

• ¹Department of Gastroenterology, Dietetics and Internal Diseases, Poznan University of Medical Sciences, Poznan, Poland
• ²Department of Internal Medicine, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA, Weston, United States
• ³R&D Department, AronPharma Ltd., Trzy Lipy Street 3, 80-172 Gdansk, Poland, Gdansk, Poland
• ⁴Institute of Human Genetics, Polish Academy of Sciences, Poznań, Greater Poland, Poland
• ⁵3P-Medicine Laboratory, Medical University of Gdańsk, Dębinki Street 7, 80-211 Gdańsk, Poland, Gdansk, Poland

Irritable bowel syndrome (IBS) is the most prevalent functional bowel disorder impacting around 5-10% of the general population worldwide. The pathogenesis remains unclear, however alterations in gut-brain axis play a critical role. We aimed to investigate the therapeutic potential of a novel synbiotic formulation comprising of partially hydrolyzed guar gum (PHGG), specific probiotic strains (Bifidobacterium and Saccharomyces Boulardii), and double-standardized, polyphenol-rich blend of extracts from Aronia melanocarpa and Sambucus nigra in patients with IBS.A total of 47 patients with IBS were randomly assigned to three groups and followed over a two-month study period. Group I (n=14) received placebo capsules, Group II (n=14) took one placebo capsule along with a probiotic formulation and PHGG, Group III (n=19) received probiotic formulation, PHGG and polyphenol-rich fruit extracts blend. The IBS-quality of life (QoL) questionnaire was completed by all participants at baseline and after two months. Serum levels of IL-6, IL-8, TNF-α, I-FABP-2, GM-CSF and stool concentrations of short-chain fatty acids (SCFAs) and zonulin were evaluated before and after intervention. This study demonstrated a significant improvement in QOL in individuals receiving the complete formulation combination (Group III). The largest decrease in score was observed in dysphoria, with median differences of -5 in Group III (p=0.0021), -3 in Group II (p=0.0155), and -1 in the control Group I (p=0.0338). Significant correlations were found in Groups II and III between supplementation and serum concentrations of IL-8, TNF, and GM-CSF (p<0.05). A significantly higher concentration of all SCFAs was seen after intervention in Group III compared to control Group I.