Abstract:
A randomized, placebo-controlled, double-blind, parallel-group clinical study was conducted to examine the effects of ingesting a heat-killed lactic acid bacterium, Lactobacillus johnsonii No. 1088 (LJ88) on temporal gastroesophageal reflux-related symptoms in healthy volunteers. A total of 120 healthy Japanese volunteers of both sexes, aged between 21 and 63 years, whose Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) total score was 8 or greater, but who were not diagnosed with functional dyspepsia according to the Rome IV classification, were enrolled. They were randomly assigned to either the LJ88 or placebo group and instructed to ingest the test food (1 billion heat-killed LJ88 or placebo) once a day for six weeks. Gastroesophageal reflux-related symptoms were evaluated using FSSG scores as a primary endpoint. The Gastrointestinal Symptoms Rating Scale (GSRS), stomach state questionnaire, and serum gastrin concentration were used as secondary endpoints. In the FSSG evaluation, the heartburn score was significantly improved at 6 weeks in the LJ88 group compared to the placebo group. No severe adverse events related to the test food were observed. In conclusion, daily ingestion of heat-killed LJ88 improved temporal heartburn symptoms in non-diseased individuals.
摘要:
一个随机的,安慰剂对照,双盲,进行了平行组临床研究,以检查摄入热杀死的乳酸菌的影响,约翰森氏乳杆菌编号。1088(LJ88)对健康志愿者的颞期胃食管反流相关症状的影响。共有120名男女健康的日本志愿者,年龄在21至63岁之间,胃食管反流病(FSSG)症状的频率量表总分为8或更高,但根据罗马IV分类,他们没有被诊断为功能性消化不良,已注册。他们被随机分配到LJ88或安慰剂组,并指示每天一次摄入测试食物(10亿个热灭活的LJ88或安慰剂),持续六周。使用FSSG评分作为主要终点评估胃食管反流相关症状。胃肠道症状评定量表(GSRS),胃状态问卷,和血清胃泌素浓度被用作次要终点。在FSSG评估中,与安慰剂组相比,LJ88组6周时的胃灼热评分显著改善.没有观察到与测试食物相关的严重不良事件。总之,每日摄入热灭活LJ88可改善非患病个体的颞部胃灼热症状。