A Randomized, Double-Blind, Placebo-Controlled Trial Investigating a Probiotic Blend on Supporting Digestive Health in Older Adults with Occasional Constipation

Objectives: Gastrointestinal (GI) issues, including constipation, are common among older adults and may be associated with changes in gut microbiota activity or composition. It has been previously shown that Lactiplantibacillus plantarum KABP-31 and KABP-32 have a beneficial effect on digestive health in older adults. The objective of this study was to examine the efficacy of a probiotic blend containing these two strains (FloradaptTM Mature Immune Defense) on GI symptoms, bowel movement (BM) frequency, stool consistency and mental well-being. Methods: This randomized, double-blind, placebo-controlled study consisted of an 84-day supplementation period with a 21-day run-in period. Participants were healthy men and women between 50-85 years old with occasional constipation, as defined by infrequent BMs, straining during defecation and hard stool consistency. At baseline, day 42 and 84, GI symptoms and bowel function were assessed by the Gastrointestinal Symptoms Rating Scale (GSRS) and daily bowel habits diary. Participant's perceived stress and quality of life (QoL) was assessed by the Perceived Stress Scale (PSS) and 12-Item Short Form Survey (SF-12), respectively. Results: Stool consistency improved throughout the study period, with a 35.2% greater improvement after 42 days of probiotic supplementation compared to placebo (p=0.002). Within-group, probiotic supplementation improved BM frequency by +1.89 and +1.62 BM/week after 42 and 84 days, respectively (p< 0.001). At day 84, total GI symptoms improved by 36.6% and 31.1% in the probiotic and placebo groups, respectively (p< 0.001). There was a 16.3% reduction in perceived stress in the probiotic group after 84 days (p=0.048), along with a significantly lower proportion of participants reporting moderate stress compared to the placebo group (9.4% vs. 37.9%). There were no other differences in GI symptoms, BM frequency or QoL between groups. Conclusions: A probiotic blend containing L. plantarum KABP-31 and KABP-32 strains improved constipation, and stress in a population of older adults experiencing occasional constipation. These findings suggest this probiotic may not only help alleviate constipation symptoms but also influence the gut-brain axis and improve the mental well-being of this population. Funding Sources: Kaneka Americas Holding Inc.