Ala-Jaakkola Reeta, Forssten Sofia D, Cheng Jing, Griffon Flavie, Metreau Isabelle, Sturm Yves, Lecerf Jean-Michel, Donazzolo Yves, Junnila Jouni, Nordlund Anders, Hibberd Ashley, Ouwehand Arthur C, Ibarra Alvin
Health Sciences, International Flavors & Fragrances, Kantvik, Finland.
Biofortis, route de la chatterie, Herblain, France.
Mol Nutr Food Res. 2025 Sep;69(17):e70081. doi: 10.1002/mnfr.70081. Epub 2025 May 5.
Functional constipation (FC) is characterized by difficult, infrequent, or incomplete bowel movements without clear physiological cause. Daily intake of Bifidobacterium lactis HN019 has been shown to reduce colonic transit time or increases bowel movement frequency in 2-4 weeks interventions. This triple-blind, randomized, placebo-controlled clinical trial assessed the effect of 8 weeks HN019 supplementation on complete spontaneous bowel movement (CSBMs) in adults with FC (diagnosed by Rome III criteria). Furthermore, stool consistency, degree of straining, abdominal pain severity, bloating severity, PAC-SYM, PAC-QoL, and use of rescue medication were assessed. Participants were screened at four clinical units in France for 2 weeks to confirm eligibility: no safety concerns, ≤3 CSBMs/week (recorded in daily diaries), followed by an 8-week intervention with daily supplementation of HN019 or placebo. HN019 was not found to be superior in managing FC compared to placebo. Fecal samples were collected from 50% of the participants for analyses of moisture content, microbiota, microbial metabolites, and calprotectin. These did not show any significant differences between the groups. This study did not support the expected effect of HN019 on improving CSBM frequency in participants with FC. No safety concerns related to B. lactis HN019 supplementation were identified. Trial Registration: ClinicalTrial.gov: NCT04231162.
功能性便秘（FC）的特征是排便困难、次数少或不完全，且无明确的生理原因。在为期2至4周的干预中，每日摄入乳酸双歧杆菌HN019已被证明可缩短结肠转运时间或增加排便频率。这项三盲、随机、安慰剂对照临床试验评估了8周补充HN019对符合罗马III标准诊断的成年FC患者完全自主排便（CSBMs）的影响。此外，还评估了粪便稠度、用力程度、腹痛严重程度、腹胀严重程度、PAC-SYM、PAC-QoL以及急救药物的使用情况。参与者在法国的四个临床单位接受了为期2周的筛查以确认 eligibility：无安全问题，每周CSBMs≤3次（记录在每日日记中），随后进行为期8周的干预，每日补充HN019或安慰剂。与安慰剂相比，未发现HN019在治疗FC方面更具优势。从50%的参与者中收集粪便样本，分析其水分含量、微生物群、微生物代谢物和钙卫蛋白。这些在两组之间未显示出任何显著差异。本研究不支持HN019对改善FC参与者CSBM频率的预期效果。未发现与补充乳酸双歧杆菌HN019相关的安全问题。试验注册：ClinicalTrial.gov：NCT04231162。 （注：原文中“eligibility”未明确中文释义，可根据上下文理解为“符合条件”之类的意思，这里保留英文未译）
