jRCTs031210344已完成不适用
A Single-Center, Prospective, Open(masking not use), Single Arm Study. Examination of the effectiveness of probiotics for elderly patients with chronic constipation.
未提供0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Amount of change in defecation score on the Bristol Stool Form Scale
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 65age old over 至 90age old not（—）
- 性别
- All
入选标准
- •1.Males and females between 65 and 90 years of age at the time of consent.
- •2.Patients who have been diagnosed with chronic constipation by ROME IV.
- •3.Patients who have given their written consent to participate in this study.
排除标准
- •1.Patients corresponding to 6 (muddy stool) and 7 (watery stool) on the Bristol Stool Form Scale.
- •2.Patients who have or are suspected of having abnormal recto-anal function.
- •3.Patients who have been diagnosed with organic abnormalities that cause constipation by colonoscopy within 5 years.
- •4.Patients with a history of surgical resection of the stomach, gall bladder, small intestine, or large intestine (except for appendicitis and benign polypectomy).
- •5.Patients with a history of or currently suffering from celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), or ischemic colitis.
- •6.Patients who currently have infectious enteritis.
- •7.Patients with obvious mechanical obstruction (intestinal obstruction due to hernia, etc.), giant colon, or giant rectum.
- •8.Patients who have had or are currently suffering from malignant tumors of the digestive system (except for gastrointestinal cancers that have been cured by endoscopic treatment).
- •9.Patients who are currently suffering from serious cardiovascular, respiratory, renal, hepatic, digestive (except for chronic constipation), hematological, neurological, or psychiatric diseases (including insomnia with constant use of sleeping pills, but not including patients who take sleeping pills only for insomnia).
- •10.Patients who have had or are currently suffering from Parkinson's disease.
- •11.Patients who are currently suffering from hyperthyroidism or hypothyroidism.
- •12.Patients who have participated or are currently participating in clinical trials, post-marketing clinical trials, or clinical research for other ethical drugs or medical devices within three month prior to obtaining consent.
- •13.Patients who are abusing alcohol and drugs.
- •14.Patients with a history of allergy caused by the study drug (study drug: lactobacillus, saccharobacillus, butyric acid bacteria, additives).
- •15.Patients who regularly use probiotics other than the protocol treatment (However, even if they have been discontinued more than 2 weeks prior to enrollment.)
- •16.Patients who regularly use medicines that affect bowel movements (antibiotics, diarrheals) or health foods/supplements (lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, etc. However, foods such as yogurt are acceptable.).
- •17.Other patients who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.
结局指标
主要结局
Amount of change in defecation score on the Bristol Stool Form Scale
时间窗: between pre-treatment and treatment week 8 (day 56)
The stool properties score (1-7) on the Bristol Scale is used as the score, and the score is set to "0" on days when there is no defecation. Defined as the total of the values obtained by subtracting 4, which is considered to be a normal stool on the Bristol Scale, for 7 consecutive days. If there is a missing measurement in seven consecutive days, the average value of the data excluding the missing days is adopted.
次要结局
- Amount and rate of change in the number of bowel movements(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Amount of change in the defecation score of the Bristol Stool Form Scale(pre-treatment to treatment week 4 (day 28))
- Amount and rate of change in JPAC-QOL total score and each subscale score(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Amount and rate of change in ModifiedCSS (mCSS) total score and each endpoint(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Amount and rate of change in each questionnaire score(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Amount and rate of change in the severity of strain score(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Amount and rate of change in TG/HDL-C ratio(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Amount and rate of change in nutritional status assessment(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
- Variation and rate of change in intestinal microflora(pre-treatment to treatment week 4 (day 28), pre-treatment to treatment week 8 (day 56))
研究者
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