A Probiotic Double-blind Randomized Placebo Crossover Trial of Colonic Transit Time in Adult Females, The PRIDE Study The Study to Determine the Effects of Probiotics on Regulation and Improving Digestive hEalth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Colonic Transit Time
研究概览
简要总结
The purpose of this study is to determine the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved gastrointestinal comfort and quality of life compared to those receiving the non-probiotic supplemented yogurt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being female
- •Ability to speak and write English or Spanish
- •Willingness to refrain from specified probiotic supplements, during the 12 week trial (a list of prohibited products will be provided)
- •Have access to refrigeration and phone
- •Have a history of straining during bowel movements
- •Have a history of lumpy or hard stools
排除标准
- •Presence of an allergy or intolerance to any ingredients in yogurt
- •Morbid obesity, defined as a BMI>40
- •Having inflammatory bowel disease
- •Having a history of malabsorption syndrome
- •Immunodeficiency, such as HIV or currently receiving chemotherapy
- •Consumption of any medications used to treat, prevent or cure diarrhea in the last month
- •Consumption of any medications used to treat, prevent or cure constipation in the last month
- •Diabetes mellitus
- •Thyroid disorders, including hypo- or hyperthyroidism
- •History of gastric, small bowel or colonic resection
- •Documented history of gastric emptying disorder
- •Consumption of narcotics, antipsychotic medications, or verapamil in the last month
- •Known pelvic outlet obstruction
- •Antibiotic usage within 4 weeks of enrollment
- •Pregnancy
研究组 & 干预措施
Bifidobacterium supplemented yogurt
Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus
干预措施: Probiotic strain of Bifidobacterium (Other)
Placebo Yogurt
Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus
干预措施: No Bifidobacterium (Other)
结局指标
主要结局
Colonic Transit Time
时间窗: 90 days
次要结局
- Adverse events(90 days)
- Frequency of bowel movements (daily)(90 days)
- Stool consistency (daily)(90 days)
- Well being as assessed by agreed upon quality of life instrument(90 days)
- Dietary intake survey(90 days)
- Tolerance(90 days)
- Rome criteria(90 days)
- Bristol criteria(90 days)
- Recovery of the probiotic in the faeces (quantitative measure)(90 days)
- Bacterial composition of the fecal flora(90 days)