Study Results: Pragmatic evaluation of the implementation of probiotics in elderly care (prOud)

Pragmatic evaluation of the implementation of probiotics in elderly care (prOud)

The elderly population, namely that above the age of 65, is growing fast every year. With aging, many complications, (such as impaired gastrointestinal function and reduced senses of smell and taste), appear and often lead to malnutrition. The aging process confronts elderly people with complex medical issues associated with a disturbance of the gut microbiota and, as a result, a decline in immune functions. Due to suppressed immune responses, the elderly are more susceptible to infections and the consequences of those infections. An especially vulnerable population is elderly people in care institutions, due to their crowded living conditions. It has been estimated that up to 10% of nursing home residents are on antibiotic treatment at any moment. For elderly people in care institutes, antibiotics are often prescribed for treatment of pneumonia and urinary tract infections. The use of antibiotics is not without severe side effects; a common side effect is antibiotic-associated diarrhea (AAD) (Allen 2013). Elderly people, specifically those in care institutions, who often use  antibiotics, are therefore more prone to develop  AAD. In elderly people, AAD is often linked to additional health risks such as malnutrition and dehydration (Hood 2014), as well as to a higher risk of reinfection, with again antibiotic prescription and perhaps a second case of AAD as a consequence, all resulting in a poor quality of life. Diarrhea in elderly people also increases the workload of care staff, which places an additional burden of costs on the healthcare system.
AAD is caused by dysbiosis of the intestinal microbiota and the (opportunistic) growth of specific pathogens that take the place of the commensal species killed by antibiotics. Antibiotic use can even increase the risk of colonization with antibiotic-resistant microorganisms. One way to restore the intestinal microbiome is by using beneficial microorganisms known as probiotics. At Winclove Probiotics, we have studied earlier the effect of particular probiotics for the prevention of AAD. To this end, based on numerous studies, we have shown that Ecologic® AAD can prevent the occurrence of AAD (Koning 2007, Lang 2010, Hell 2013). However, probiotics are recommended to elderly people only rarely (at least in the Netherlands) and are implemented poorly in elderly care institutes.
Therefore, the main goal of our PrOud Study was to gain insight into the opportunities and barriers for implementation of probiotics, such as Ecologic® AAD, in care institutes (Wietmarschen 2020). Especially since the impact of AAD on quality of life and the resulting additional costs are exceptionally high, and the beneficial effects of certain probiotics on AAD are well documented.

The study was performed in collaboration with elderly care physicians, dieticians, pharmacists and researchers of the Rivas Zorggroep (Gorinchem, the Netherlands), the Louis Bolk Institute (Bunnik, the Netherlands) and the Van Praag Institute (Utrecht, the Netherlands).

The study aimed to:
·    Support implementation of probiotics in elderly care institutes to reduce AAD;
·    Evaluate the effect of probiotics on AAD and compare with control data (quantitative);
·    Evaluate the process of implementation (qualitative).

The PrOud study was designed as a pragmatic participation evaluation and included 93 nursing home residents with 167 episodes of antibiotic use. The study’s strength lies in the fact that we compare the probiotic treatment period with data on antibiotic use recorded for the residents prior to the study, which means that some patients serve as their own control. Hence, a treatment group of total 71 patients received probiotics during a course of antibiotics and a control group of 49 patients  did not receive probiotics (pre-recorded data). The patients in the control group received in total 83 courses of antibiotics, and 36% of these patients developed diarrhea. A total of 84 courses of antibiotics were prescribed in the treatment group. Diarrhea occurred in 20% of these cases, which was significantly lower (p=0.022) than in the control group. Further, the benefits of taking Ecologic® AAD could also be observed in part of the intervention group that serves as their own control. Hence, 27 patients received antibiotics during the control period (no probiotics) as well as during the intervention period (probiotics in addition to antibiotics). During the control period, 14 of the 27 (52%) patients developed AAD after taking antibiotics. In the test period, when patients received probiotics in addition to the antibiotic course, 4 of the 27 patients, (15%), suffered from diarrhea. More specifically, of those patients with a history of AAD development during the control period, only 3 of  14 suffered from diarrhea during the test period, which corresponds to a 78% reduction. In both the control period and the period involving probiotic use, the number of patients who did not develop diarrhea remained the same. Although still in an explorative phase, this study provided further insights into potential effects on reduction of the number of re-infections, and thus second antibiotic courses. Two of the 27 patients had up to 6-7 antibiotic courses in the test period, in comparison to 1 or 2 antibiotic courses when probiotics were taken. This suggests that probiotics possibly might have a long-term effect and break the vicious circle of new infections and repeated antibiotic use in care institutes. This finding should be elucidated further in follow-up research.

The PrOud pilot study demonstrates that probiotic use results in fewer AAD episodes among elderly patients in care institutions. Furthermore, the study was also done to investigate the potential of implementation in practice. The implementation approach used in this study has shown to be successful, and required the cooperation from all health care providers, including physicians, dieticians and pharmacists. Dieticians are the permanent contact point for care staff answering practical questions and facilitating the implementation of the probiotics. Care institute residents also show curiosity about and desire for probiotic use, since probiotics fit in the trends towards healthy lifestyles and prevention.

The main lessons learned from the PrOud study for successful and sustainable implementation are:

• Pragmatic research can support the implementation of probiotics in daily care;
• Implementation works well, with support throughout the health care chain;
• The combination of enthusiastic doctor and dietician is crucial for successful implementation;
• Prescription of probiotics by physicians and making it part of the medication list, whereby the doctor is ultimately responsible, lead to better compliance;
• Good instructions on practical use are helpful, especially as providing probiotics takes extra time and might sometimes be difficult in this population.
• The personalization and tailoring of advice and of use is crucial; it is not necessary to provide all patients with probiotics, but especially those with a history of Protocol with “if-then” statements to personalize the use of probiotics.

Implementation of probiotics for elderly people, especially those in care institutes, opens new horizons for probiotics use. Still, we have shown that Ecologic® AAD has excellent potential for the successful implementation in a new market segment and future growth.

References:
The PrOud Study: Wietmarschen et al. 2020 Probiotics use for antibiotic-associated diarrhea: a pragmatic participatory evaluation in nursing homes. BMC Gastroenterology (2020) 20:151
Allen SJ et al. 2013 Lancet, 382(9900), 1249–1257.
Hell M et al. 2013 Beneficial Microbes, 4(1), 39–51.
Hood K et al. 2014 Health Technology Assessment, 18(63).
Koning CJM et al. 2007 American Journal of Gastroenterology, 102(1), 1–12.
Lang et al. 2010 Nutra Foods, 9(2) 27-31