파라바이오틱스의 건강기능식품 등재를 위한 안전성 및 기능성 평가와 규제검토 : 체계적 문헌고찰과 메타분석
Safety and Efficacy Evaluation and Regulatory Review for Registration of Parabiotics as Health Functional Foods : Systematic Literature Review and Meta-analysis
As the association between the gut microbiota and human health has become well established, interest in functional ingredients for gut health has continued to grow. Although the domestic health functional food market has expanded rapidly, conventional probiotics have inherent limitations, including issues related to the stability of live microorganisms and the potential risk of infection in immunocompromised individuals. Parabiotics, defined as inactivated probiotic cells, do not contain viable microorganisms and have therefore attracted attention as an alternative that may overcome the safety and stability limitations of existing probiotic products. This study comprehensively examined the health-promoting effects of parabiotics and explored their potential as functional food ingredients, along with related regulatory implications. A synthesis of the studies included in the metaanalysis indicated that parabiotics generally exhibited favorable effects on immune modulation, inflammation reduction, and metabolic improvement. The pooled effect size was estimated to be in the moderate-to-large range; however, statistical significance was not achieved due to substantial heterogeneity across studies. Nevertheless, several individual studies demonstrated pronounced effects under specific conditions, suggesting that parabiotics may exert clinically meaningful benefits in certain strains or specific target populations. The high degree of heterogeneity among studies indicates that the effects of parabiotics may vary according to strain characteristics, intervention methods, and the immune status of the target population, highlighting the need for a more personalized approach rather than a uniform evaluation framework. In particular, effects appeared to be limited in healthy adult populations, whereas more pronounced improvements were observed in populations with immune imbalance or inflammatory conditions. A comprehensive review of domestic and international regulatory environments suggests that the characteristics of parabiotics are not adequately reflected within existing probioticcentered evaluation systems. For their inclusion as health functional food ingredients in Korea, improvements to current evaluation criteria, accumulation of large-scale human studies, and establishment of standardized manufacturing and quality control guidelines are required. This study provides scientific evidence supporting the potential public health applicability of parabiotics as next-generation functional ingredients that combine safety and efficacy. In the context of increasing public health burdens associated with population aging and the growing prevalence of chronic diseases, parabiotics may represent a valuable preventive health management option that can be used relatively safely even by immunocompromised individuals.
목차
Abstract I. 서론 II. 연구 방법 1. 파라바이오틱스 개념 정립 방법론 2. 체계적 문헌고찰 프로토콜 3. 메타분석 통계 방법 III. 연구 결과 및 고찰 1. 파라바이오틱스의 개념 정립 및 분류 2. 체계적 문헌 고찰 결과 3. 메타분석 결과 4. 국내외 건강기능식품 규제 현황 분석 5. 고찰 IV. 향후 연구 방향 및 제언 참고문헌 부록
한국에프디시규제과학회(구 한국에프디시법제학회) [The Korean Society of Food, Drug and Cosmetic Regulatory Sciences]
설립연도
2006
분야
의약학>약학
소개
본회는 의약품, 의약외품, 의료기기, 화장품 및 건강기능식품 등과 관련된 국내·외의 각종 법령과 규정 등에 대한 연구와 발표 등을 통하여 합리적이고 투명한 법령과 규정의 제·개정 및 정책개발에 기여함으로써 관련 산업의 발전과 국민의 건강증진에 기여하며 회원 상호 간의 친목을 도모함을 목적으로 한다.
간행물
간행물명
KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]