Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial

Lina Östlund-Lagerström, Annica Kihlgren, Dirk Repsilber, Bengt Björkstén, Robert J Brummer, Ida Schoultz, Lina Östlund-Lagerström, Annica Kihlgren, Dirk Repsilber, Bengt Björkstén, Robert J Brummer, Ida Schoultz

Abstract

Background: Diseases of the digestive system have been found to contribute to a higher symptom burden in older adults. Thus, therapeutic strategies able to treat gastrointestinal discomfort might impact the overall health status and help older adults to increase their overall health status and optimal functionality.

Objective: The aim of this double-blinded, randomized, placebo-controlled clinical trial was to evaluate the effect of the probiotic strain Lactobacillus reuteri on digestive health and wellbeing in older adults.

Methods: The study enrolled general older adults (>65 years). After eligibility screening qualified subjects (n = 290) participated in a 2-arm study design, with each arm consisting of 12 weeks of intervention of either active or placebo product. Primary outcome measure was set to changes in gastrointestinal symptoms and secondary outcome measures were changes in level of wellbeing, anxiety and stress. Follow up was performed at 8 and 12 weeks.

Results: No persistent significant effects were observed on the primary or secondary outcome parameters of the study. A modest effect was observed in the probiotic arm, were levels of stress decreased at week 8 and 12. Similarly, we found that subjects suffering from indigestion and abdominal pain, respectively, showed a significant decrease of anxiety at week 8 after probiotic treatment, but not at week 12.

Conclusion: The RCT failed to show any improvement in digestive health after daily intake of a probiotic supplement containing L. reuteri. Neither was any significant improvement in wellbeing, stress or anxiety observed. Even though the RCT had a negative outcome, the study highlights issues important to take into consideration when designing trials among older adults.

Trial registration: Clinicaltrials.gov/ NCT01837940 .

Keywords: Digestive health; Lactobacillus reuteri; Older adults; Probiotics; Wellbeing.

Figures

Fig. 1
Fig. 1
Participant flow and adverse events
Fig. 2
Fig. 2
Changes in the primary outcome parameter over the study period. The figure shows change from baseline in GSRS total mean score in the two treatment groups, throughout the intervention period. 178 subjects were included in the analysis, excluding participants taking PPI and GMMS during the study. (Prob) indicates the probiotic group receiving treatment with L. reuteri (n = 86) and (PL) indicates the placebo group (n = 92)
Fig. 3
Fig. 3
Changes in psychological distress for subjects with elevated stress at baseline. The figure shows the 37 subjects with baseline PSS score ≥15, (Prob) indicates the probiotic group receiving treatment with L. reuteri (n = 17) and (PL) indicates the placebo group (n = 20). A modest effect was found for the probiotic treatment to decrease symptoms of stress over the study period (4.53 ± 4.25 compared to 2.2 ± 4.5 for placebo treatment, respectively (p = 0.20, statistical test: Mann-Whitney U-test))

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Source: PubMed

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