JPRN-UMIN000028830已完成未知
Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study - Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency
TTC Co., Ltd.0 个研究点目标入组 60 人开始时间: 2018年10月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
The changes in stool frequency between the two periods in the per protocol population (n=58) were mean3.0 SD3.0 and mean1.6 SD2.9 times/2 weeks in B.coagulans-containing food group and placebo group, respectively (P=0.09). The intergroup difference was significant in the population (n=53) after excluding subjects who took an antibiotic or experienced a change in eating habit (mean3.0 SD3.0 and mean1.2 SD2.8 times/2 weeks in B.coagulans-containing food group and placebo group, respectively, P=0.03). No significant intergroup differences were found in the changes in stool properties, defecation amount, and intestinal flora pattern.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 64years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Subjects routinely taking medicine or health food which may influence bowel movement and take foods of lactic acid bacteria. (2) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (3) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy) (4) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (5) Subjects who are under medication or having a history of serious diseases for which medication was required (6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality (8) Subjects having possibilities for emerging allergy related to the study (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (13) Subjects judged as unsuitable for the study by the investigator for other reasons
研究者
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