The Efficacy of Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota (LcS) on Relieving Constipation-Related Symptoms of Filipino Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in stool consistency
研究概览
简要总结
The primary purpose of this study is to investigate whether the consumption of a probiotic drink (with Lacticaseibacillus paracasei strain Shirota (LcS)) relieves constipation-related symptoms of Filipino adults, specifically its effect on stool consistency, frequency, and duration, and on gastrointestinal discomfort.
详细描述
The goal of this clinical trial is to test if probiotic drink with LcS consumption can improve constipation-related symptoms. The main question[s] it aims to answer are:
- Will a probiotic drink with LcS improve stool consistency after four weeks?
- Will a probiotic drink with LcS improve stool frequency and duration after four weeks?
- Will a probiotic drink with LcS improve gastrointestinal discomfort after four weeks?
Participants will consume probiotic drink with LcS once a day for four weeks while maintaining their usual physical activity. Researchers will compare the control group and the probiotic group to see if there are differences in stool consistency, frequency and duration, and gastrointestinal symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Data encoder, Statistician
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Filipino adult male or female aged 18 to 59 years old
- •Apparently healthy adults with constipation-related symptoms of hard to lumpy stools (Bristol Stool Form Scale 1-2) in 25% or more of defecations in a week
- •With cold storage at home
排除标准
- •Habitual intake of food items containing probiotics and prebiotics as food supplements (previous 3 months, at least three times per week)
- •Constipation due to organic or neurologic origin
- •High fiber intake (>30 g/day)
- •Pregnant or lactating
- •Allergy to dairy products and/or lactose intolerance
- •Use of laxatives, anticholinergics and medications for constipation or diarrhea within the past three months
- •Use of antibiotics within the past two weeks
- •Presence of chronic diseases such as diabetes mellitus and its complications, cardiovascular diseases, kidney problems
- •GI condition that may interfere with the evaluation of the outcome such as hemorrhoids, intestinal obstruction and inflammatory bowel diseases
- •Recent history of any gastrointestinal surgery
- •Have pre-existing medical conditions like hypo- or hyperthyroidism and congenital abnormalities
- •Participation in another study with test product two months prior the study
研究组 & 干预措施
Probiotic
Probiotic drink with Lacticaseibacillus paracasei strain Shirota will be consumed once per day for four weeks. Brochure containing recommendations to improve constipation will be provided at the start of study.
干预措施: Experimental: Probiotic with LcS (Other)
Control
Brochure containing recommendations to improve constipation will be provided at the start of study.
干预措施: Control (Other)
结局指标
主要结局
Change in stool consistency
时间窗: Four weeks
Bristol Stool Consistency Score: Type 1: Separate hard lumps, like nuts (hard to pass); Severe Constipation. Type 2: Sausage-shaped, but lumpy; Mild Constipation. Type 3: Like a sausage, but with cracks on its surface; Normal. Type 4: Like a sausage or snake, smooth and soft; Normal. Type 5: Soft blobs with clear-cut edges (passed easily); Borderline Normal. Type 6: Fluffy pieces with ragged edges, a mushy stool; Mild diarrhea. Type 7: Watery, no solid pieces, entirely liquid; Severe diarrhea.
次要结局
- Change in the Duration of Bowel Movement(Four weeks)
- Change in the Frequency of Bowel Movement(four weeks)
- Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms)(four weeks)
研究者
Diane S. Mendoza-Sarmiento
Principal Investigator
University of Santo Tomas