Correlations between symptoms and quality of life: a real-world study of a five-strain spore-forming Bacillus probiotic supplement in US adults with ‘leaky gut’ symptoms
Introduction
Gastrointestinal and extra-intestinal symptoms associated with ‘leaky gut’ may impair quality of life (QoL). Probiotics may improve gastrointestinal symptoms, QoL, and intestinal barrier function. This real-world study explored symptoms and QoL in US adults reporting leaky gut symptoms.
Objective
Probiotics are commonly used by individuals who report symptoms ascribed to ‘leaky gut’, due to their demonstrated effects in various gastrointestinal conditions and quality of life, and their role in maintaining intestinal barrier function [1]. This real-world, open-label, single-arm study explored correlations and changes in leaky gut-associated symptoms and quality of life in US adults, following probiotic supplementation.
Method
Adults in the US reporting symptoms commonly ascribed to ‘leaky gut’ took a probiotic supplement (4 billion CFU/day: Bacillus indicus HU36™, Bacillus licheniformis [SL-307], Bacillus clausii [SC-109], Bacillus subtilis HU58™, Bacillus coagulans [SC-208]) for 4 weeks. Self-reported baseline and week 4 data from online questionnaires were compared to explore changes in frequency (0-7 days) and intensity (Likert scale: 1-10, least-most) of symptoms, overall impact (Likert scale: none-big) of symptoms on life, wellbeing (Likert scale: 1-10; worst-best), number of foods avoided and missed days (last 4 weeks) of work and social/leisure activities. Correlations between baseline symptoms and QOL outcomes were explored.
Results
Data from 238 adults (88% retention from baseline; 85.3% female; 44.1±9.91 years) were analysed. At baseline, predominant symptoms were bloating (100%), indigestion/abdominal discomfort (100%), excessive/foul-smelling gas (100%), fatigue (100%), uncomfortable fullness after eating (83.2%) and joint pain (80.3%), followed by headache/migraine (66.8%), brain fog/confusion/difficulty concentrating (63.5%), reduced appetite (45.8%) and skin problems (43.3%). At week 4, the frequency of all symptoms significantly reduced, occurring on 1.00-3.06 fewer days within the last week, compared to baseline (p<0.001). Significant reductions were also seen in symptom intensity (Figure), impact to life, wellbeing (6.73±1.73 vs. 5.36±1.72), number of avoided foods (2.40±7.47 vs. 6.53±13.16) and missed days of work (0.45±1.75 vs. 1.51±3.46) and social/leisure activities (0.91±2.44 vs. 3.49±4.30) (all p<0.001). All symptoms significantly correlated to QoL outcomes (p<0.05). In particular, the strongest correlations were seen between impact to life, bloating, fatigue, fullness, gas and indigestion, and between overall wellbeing, confusion and fatigue.
Conclusion
B. lactis Fit™ has anti-obesity potential by regulating lipid metabolism in both animal and human models. It effectively reduces body weight, body fat, and triglyceride levels. These findings support its potential as a functional ingredient for obesity management.
Patent/Patent Application ID - Composition for reducing body fat comprising Bifidobacterium lactis IDCC 4301/10-2445708 (KOR)
Clinical Trial Registration - This clinical study was approved by the Institutional Review Board of Kyung Hee University Hospital (no. KHUH 2022-01-069) and registered at CRIS (KCT0007425).