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WANG et al .
FIGURE 6 Spearman correlation heat map between SCFAs and relative abundances of fecal microbiota at the genus level from subjects based on both LP N1115 and placebo groups post- intervention. Values range from low (blue) to high (red)
including Alistipes and Akkermansia were found to be positively correlated with 2-methyl propanoic acid ( r = .38, p < .05; r = .32, p < .05) and 3-methyl butanoic acid ( r = .39, p < .05; r = .38, p < .05), respectively.
the safety and efficacy of LP N1115 supplementation on gastro - intestinal symptoms, salivary cortisol, gut microbiota, and SCFAs levels in a cohort of healthy, young children born by C-section. A ran - domized, placebo-controlled design was employed to minimize bias when comparing efficacy data during the intervention. The probiotic was found to be safe and well tolerated by all subjects throughout the study. Results showed that after 8 weeks of probiotic admin - istration with a daily dose of 10 9 CFU, gastrointestinal symptoms, cortisol levels, and fecal characteristics were generally similar for the placebo and LP N1115 groups. When examining stool consistency as the primary efficacy variable, the results were similar between LP N1115 and placebo consumption overtime. This was not surprising given the fact that our study population was deemed as healthy; thus, this check was utilized to observe any adverse events related to the investigational product. Interestingly, when results from the additional subgroup analysis (6–18 months) were examined, a large effect size between LP N1115 and placebo groups overtime was found. Although the statistical comparison was nonsignificant, a trend in the data was observed with LP N1115 group moving from soft stools at base - line toward normal stools by week 8, whereas the placebo group moved toward softer stools by week 4 and returned to soft stools by week 8. Sample size was considered small in this subgroup, therefore, caution must be exercised when interpreting these find - ings. In some cases, the effects of LP N1115 are reported to be more pronounced in studies where gastrointestinal disorders are diagnosed. For example, a study by Urita et al. (2015) demonstrated that consumption of a fermented milk for 4 weeks containing Bifidobacterium bifidum YIT 10347 significantly improved gastroin - testinal and psychological symptoms in patients aged 12–80 years. Similarly, Indrio and colleagues reported that prophylactic use of Lactobacillus reuteri DSM 17938 during the first 3 months of life significantly reduced the onset of functional gastrointestinal disor - ders, thus, reducing morbidity and costs associated with healthcare (Indrio et al., 2014).
4 | DISCUSSION
Extensive research in recent years has highlighted a global concern surrounding short- and long-term health implications of C-section delivery (Betrán et al., 2016). C-section delivery is associated with an increased risk of health-related disorders such as irritable bowel syn - drome (IBS), allergy, obesity, and diabetes (Bager et al., 2008; Kuhle et al., 2015; Sevelsted et al., 2015). Of major concern is the perturba - tion of the gut microbiome as a result of C-section, and some studies have shown that C-section changes the normal microbial composi - tion by reducing its diversity, such as decreasing the colonization of Bifidobacterium and Bacteroides , as well as increasing the num - ber of Clostridium difficile , compared to vaginal delivery (Bäckhed et al., 2015; Penders et al., 2013). Clinical intervention studies using single- and multispecies probiotics, and in some cases supplemented with breast milk, have proven successful in exerting measurable ef - fects on the gut microbiota of patients (Korpela et al., 2018; Quin et al., 2018). Thus, an opportunity to deliver potential therapies from an early age to treat and prevent debilitating diseases in later life rep - resents a plausible avenue. Numerous studies have evaluated vari - ous probiotic strains, prebiotics, and synbiotics as a way of mediating immune regulation, microbial function, and diversity in C-section de - livered infants. Some of these interventions have proven successful in exerting measurable effects that help to restore the disrupted gut microbiota composition toward a microbial profile similar to vaginally delivered offspring (Chua et al., 2017; Garcia Rodenas et al., 2016; Hurkala et al., 2020; Korpela et al., 2018; Morais et al., 2020; Schultz et al., 2004). Given the promising clinical benefits associated with probiotics to date, the objective of this clinical trial was to evaluate
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