The Effect of Probiotics on Functional Constipation in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in stool frequency in patients who use probiotics
研究概览
简要总结
The main scope of the proposed research in the framework is to investigate the effect of probiotic bacteria Lactobacillus acidophilus LA3, Bifidobacterium animalis ssp. lactis BLC1 i Lactobacillus casei BGP93 on functional constipation and on the quality of life of the elderly in a nursing home. The experimental part will consists of double-blind, placebo-controlled clinical trial over 12 weeks.
详细描述
During the first four weeks, the subjects were monitored primarily concerning bowel discharges and general health. After that initial four weeks, they are re-evaluated compliance with inclusion and exclusion criteria. Participants were allocated to the double-blind section of the trial (12 weeks), using o computer-generated to a placebo group or in the probiotic group in the form of a liquid oral formulation once a day. On first day of intervention participants provide a blood sample. All investigators, participants and study personnel were blinded to the order of randomization. Participants were told to consume 9 drops of study probiotics once a day for next 12-week intervention. On last day of intervention, participants provide a blood sample. The last four weeks of the double-blind section (week 9-12) participants an evaluation period in which the respondents were evaluated for the outcomes of the study. After completing the double-blind study, the participants were followed for an additional four weeks. Inclusive / Excluded criteria are evaluated on two occasions, at the time of inclusion in the 4-week introductory section and its end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
盲法说明
A randomization list will be generated by the permutated block method (variable size 4-6) and will be kept in a sealed envelope by a person not included in the study.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 65 years or more
- •signed informed consent for study participation
- •functional constipation defined by Rome IV criteria
- •ability to understand the procedure
排除标准
- •suspicion of obstructive ileus or previous obstructive ileus
- •suspected or confirmed diagnosis: irritable colon syndrome, ulcerative colitis, Crohn's disease, malignant digestive tract disease
- •diarrhoea of any cause within the last month
- •acute infectious disease within the last month excluding people who use antibiotics
- •persons who have opioid analgesics in pharmacotherapy
研究组 & 干预措施
Placebo
liquid oral formulation 9 drops once a day
干预措施: Placebo (Other)
Probiotic
The probiotic contained Lactobacillus acidophilus LA3; 1 · 1011 CFU / g, Bifidobacterium animalis subsp. Lactis BLC1; 1.5 · 1011 CFU / g and Lactobacillus casei BGP93 2 · 1011cfu / g in the form of a liquid oral formulation
干预措施: Probalans senior (Dietary Supplement)
结局指标
主要结局
Change in stool frequency in patients who use probiotics
时间窗: 12 weeks
The proportion of subjects who meet the criterion of "normal bowel movement" according to the Roman IV criteria, at least 3 times a week to no more than 3 times a day. This proportion will be determined for each of the 4 evaluation weeks and will be analyzed as a time-averaged proportion. The proportion will be estimated on the basis of the subjects' diaries in which, by days, with indicated dates, the subjects will record each bowel emptying. Investigators would inform the evidence base with regards to the multi-strained probiotic efficacy in treating constipation among the elderly.
次要结局
- Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method(12 weeks)
- Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods(12 weeks)
- Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.(12 weeks)
- Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods(12 weeks)
- Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods(12 weeks)
- Change in LDL cholesterol at the blood of patients who use probiotics determined by standard laboratory methods(12 weeks)
研究者
Katarina Fehir Šola
Director of pharmacy
University of Zagreb