Does Daily Supplementation of Lactobacillus Acidophilus MPH734 (Lacto-FreedomTM, or LF), for One Week, Affects Acute (Immediate), Subacute (7 Days), and Post-treatment Discontinuation (30-, 60-, and 90- Day) Lactose Metabolism, Gastrointestinal Symptoms, and Clinical Markers of Inflammation and Safety Compared to a Placebo?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
研究概览
简要总结
The purpose of this study is to determine if twice or three times daily supplementation of Lactobacillus acidophilus MPH734 (Lacto-FreedomTM, or LF), for one week, affects acute (immediate), subacute (7 days), and post-treatment discontinuation (30-, 60-, and 90- day) lactose metabolism, gastrointestinal symptoms, and clinical markers of inflammation and safety compared to a placebo.
详细描述
Participants will be included and/or excluded in the study based on the criteria below:
Inclusion Criteria
- Participants will be male or female between the ages of 18-55 years;
- Participants will be apparently healthy and free from disease, as determined by a health history questionnaire;
- Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder, or is or has been prescribed to take prescription or over-the-counter medication for such;
- Participant has self-diagnosed or otherwise avoids consuming dairy, lactose, and other dairy-containing products, or regularly consumes Lactase enzymes for digestive support;
- Participant agrees and can comply with the study protocol;
- Participant provides signed and dated informed consent to participate in the study.
Subject Exclusion Criteria
- Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
- Participant is insulin-dependent or -independent diabetic.
- Participant currently uses, or has discontinued the use of nicotine-containing products within twelve (12) months of the start of the study;
- Participant lives or works within an environment that chronically exposes the subject to second-hand smoke;
- Participant currently uses, or has discontinued the use of recreational drugs or medicinal marijuana within twelve (12) months of the start of the study;
- Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease, chronic diarrhea or constipation, irritable or inflammatory bowel syndrome, Crohn's disease, or is, or has been prescribed to take prescription or over-the-counter medication for such;
- Participant has ever undergone gastric bypass surgery, or has undergone an abdominal or other gastrointestinal surgery within twelve (12) months of the start of the study;
- Participant is taking, or has taken antibiotic medications within two (2) weeks of the start of the study;
- Participant has undergone a colonoscopy within two (2) weeks of the start of the study, or is scheduled to receive a colonoscopy during the study;
- Participant has undergone a barium study or received an enema within two (2) weeks of the start of the study, or is scheduled to, or receives such during the study;
- Participant is taking, or has taken probiotics within two (2) weeks of the start of the study;
- Participant uses lactose digesting enzymes during the study;
- Participant is taking, or has taken weight loss, prebiotic [e.g., fructo- or galacto-oligosaccharides (FOS or GOS), psyllium, or insulin fiber, etc.], or laxative / stool softener dietary supplements, over-the-counter, or prescription medications within two (2) weeks of the start of the study;
- Participant is allergic to any ingredient present within the dietary supplement or placebo treatment;
- Participant reports any unusual adverse events associated with this study that, in consultation with the study investigators or the participant's doctor recommends removal from the body;
- Participant fails to comply with the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be male or female between the ages of 18-55 years;
- •Participants will be apparently healthy and free from disease, as determined by a health history questionnaire;
- •Participants will not be excluded if he or she has been clinically diagnosed with a carbohydrate malabsorption disorder, or is or has been prescribed to take prescription or over-the-counter medication for such;
- •Participant has self-diagnosed or otherwise avoids consuming dairy, lactose, and other dairy-containing products, or regularly consumes Lactase enzymes for digestive support;
- •Participant agrees and can comply with the study protocol;
- •Participant provides signed and dated informed consent to participate in the study.
排除标准
- •Participant is or may be pregnant, is trying to become pregnant, or is breastfeeding;
- •Participant currently uses, or has discontinued the use of nicotine-containing products within twelve (12) months of the start of the study;
- •Participant lives or works within an environment that chronically exposes the subject to second-hand smoke;
- •Participant currently uses, or has discontinued the use of recreational drugs or medicinal marijuana within twelve (12) months of the start of the study;
- •Participant has been clinically diagnosed with a digestive disorder such as gastrointestinal disease, chronic diarrhea or constipation, irritable or inflammatory bowel syndrome, Crohn's disease, or is, or has been prescribed to take prescription or over-the-counter medication for such;
- •Participant has ever undergone gastric bypass surgery, or has undergone an abdominal or other gastrointestinal surgery within twelve (12) months of the start of the study;
- •Participant is taking, or has taken antibiotic medications within two (2) weeks of the start of the study;
- •Participant has undergone a colonoscopy within two (2) weeks of the start of the study, or is scheduled to receive a colonoscopy during the study;
- •Participant has undergone a barium study or received an enema within two (2) weeks of the start of the study, or is scheduled to, or receives such during the study;
- •Participant is taking, or has taken probiotics within two (2) weeks of the start of the study;
- •Participant uses lactose digesting enzymes during the study;
- •Participant is taking, or has taken weight loss, prebiotic [e.g., fructo- or galacto-oligosaccharides (FOS or GOS), psyllium, or insulin fiber, etc.], or laxative / stool softener dietary supplements, over-the-counter, or prescription medications within two (2) weeks of the start of the study;
- •Participant is allergic to any ingredient present within the dietary supplement or placebo treatment;
- •Participant reports any unusual adverse events associated with this study that, in consultation with the study investigators or the participant's doctor recommends removal from the study;
- •Participant fails to comply with the study protocol.
结局指标
主要结局
Lactobacillus Acidophilus MPH734's Effect on lactose digestion in individuals who identify as lactose sensitive, intolerant, or avoid dairy.
时间窗: 97 days
Primary outcome of this study is to determine if twice or three times daily supplementation of Lactobacillus acidophilus MPH734 (Lacto-FreedomTM, or LF), for one week, affects acute (immediate), subacute (7 days), and post-treatment discontinuation (30-, 60-, and 90- day) lactose metabolism, gastrointestinal symptoms, and clinical markers of inflammation and safety compared to a placebo.
次要结局
未报告次要终点
研究者
Lemuel W. Taylor IV
Principal Investigator
University of Mary Hardin-Baylor
