Östlund-Lagerström Lina, Kihlgren Annica, Repsilber Dirk, Björkstén Bengt, Brummer Robert J, Schoultz Ida
Nutrition and Physical Activity Research Centre, Örebro University, Örebro, Sweden.
Nutrition Gut Brain Interactions Research Centre, School of Health and Medical Sciences, Faculty of Health and Medicine, Örebro University, Örebro, Sweden.
Nutr J. 2016 Sep 10;15(1):80. doi: 10.1186/s12937-016-0198-1.
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.
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.
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.
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.
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.
Clinicaltrials.gov/ NCT01837940 .
消化系统疾病已被发现会导致老年人更高的症状负担。因此，能够治疗胃肠道不适的治疗策略可能会影响整体健康状况，并有助于老年人提高其整体健康状况和最佳功能。
这项双盲、随机、安慰剂对照临床试验的目的是评估益生菌罗伊氏乳杆菌对老年人消化健康和幸福感的影响。
该研究纳入了一般老年人（>65岁）。经过资格筛选，合格受试者（n = 290）参与了双臂研究设计，每组包括12周的活性产品或安慰剂产品干预。主要结局指标设定为胃肠道症状的变化，次要结局指标为幸福感、焦虑和压力水平的变化。在第8周和第12周进行随访。
在该研究的主要或次要结局参数上未观察到持续的显著影响。在益生菌组中观察到适度的效果，即压力水平在第8周和第12周有所下降。同样，我们发现分别患有消化不良和腹痛的受试者在益生菌治疗后第8周焦虑显著降低，但在第12周没有。
随机对照试验未能显示每日摄入含罗伊氏乳杆菌的益生菌补充剂后消化健康有任何改善。在幸福感、压力或焦虑方面也未观察到任何显著改善。尽管随机对照试验有负面结果，但该研究突出了在设计针对老年人的试验时需要考虑的重要问题。
Clinicaltrials.gov/NCT01837940 。
