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.

2025-07-07
Frontiers in nutrition 12

PubMed: 40693198
DOI: 10.3389/fnut.2025.1603011

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 47
Population: 47 patients with IBS
Methods: A total of 47 patients with IBS were randomly assigned to three groups and followed over a 2-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 2 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.

Introduction

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.

Methods

A total of 47 patients with IBS were randomly assigned to three groups and followed over a 2-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 2 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.

Results and conclusions

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.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Bifidobacterium animalis subsp. lactis BLC1	—	Changes in Inflammatory Markers	Beneficial	Small	View source Significant correlations were found in Groups II and III between supplementation and serum concentrations of IL-8, TNF, and GM-CSF (p < 0.05).
Bifidobacterium animalis subsp. lactis BLC1	—	Improved Quality of Life	Beneficial	Moderate	View source This study demonstrated a significant improvement in QoL in individuals receiving the complete formulation combination (Group III).
Bifidobacterium animalis subsp. lactis BLC1	—	Increased Short-Chain Fatty Acid Production	Beneficial	Moderate	View source A significantly higher concentration of all SCFAs was seen after intervention in Group III compared to control Group I.
Bifidobacterium animalis subsp. lactis BLC1	—	Reduced IBS Dysphoria	Beneficial	Small	View source 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).
Bifidobacterium lactis UABla-12	—	Improved Quality of Life	Beneficial	Moderate	View source This study demonstrated a significant improvement in QoL in individuals receiving the complete formulation combination (Group III).