Evaluate the Safety and Efficacy of Two Enzyme Cocktails in Healthy Adults With Subclinical Mild to Moderate Gastrointestinal Complaints
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
研究概览
简要总结
The goal of this study is to determine the safety and efficacy of two enzyme cocktails in healthy adults with mild to moderate gastrointestinal discomfort. The main question aims to answer whether a 4-week administration of an enzyme cocktail can improve how the participant feels about their gut health. This is done by completing a weekly questionnaire, and the results are compared between the 4 weeks the participants are on a placebo and the 4 weeks the participants are on the enzyme cocktail. Participants will also provide a stool sample at the start and end of each treatment. Stool samples will collected and stored in case further microbiome analysis is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
- •Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study
- •Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months
- •Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis
- •Doctor diagnosed chronic disease (i.e. Diabetes, Cardiovascular, etc.)
- •Doctor diagnosed immunodeficiency
- •Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.)
- •Pregnancy, 6 months postpartum period, or current breastfeeding
- •Women of childbearing age planning pregnancy during the course of the study
排除标准
- •Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
- •Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study
- •Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months
- •Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis
- •Doctor diagnosed chronic disease (i.e. Diabetes, Cardiovascular, etc.)
- •Doctor diagnosed immunodeficiency
- •Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.)
- •Pregnancy, 6 months postpartum period, or current breastfeeding
- •Women of childbearing age planning pregnancy during the course of the study
研究组 & 干预措施
Digestive Enzyme Cocktail A
Arm receiving investigational product A
干预措施: Enzyme Cocktail A (Dietary Supplement)
Digestive Enzyme Cocktail B
Arm receiving investigational product B
干预措施: Enzyme Cocktail B (Dietary Supplement)
Placebo A
Arm receiving placebo A
干预措施: Placebo A (Dietary Supplement)
Placebo B
Arm receiving Placebo B
干预措施: Placebo B (Dietary Supplement)
结局指标
主要结局
Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
时间窗: From baseline to the end of intervention 4 weeks later.
Change in GSRS-IBS total score from baseline to end of intervention. Each question is rated on a 7 point Likert scale with higher scores representing more troublesome symptoms. Questionnaire collected weekly from baseline through study completion at the end of week 12.
次要结局
- Change from baseline in Stool Consistency at end of intervention(Through study completion, an expected average of 70 days)
- Change from baseline in the Stool Frequency at end of intervention(Through study completion, an expected average of 70 days)
- Change in Microbiome (faecal samples)(Day 0 and Day 28; Day 42 and Day 70)
- Body Mass Index (BMI)(Day 0, Day 28, Day 42, and Day 70)
- Total Fat Mass(Day 0, Day 28, Day 42, and Day 70)
- Food Intake(Day 0)
- Positive and Negative Affect Schedule (PANAS-SF)(Day 0, Day 28, Day 42, and Day 70)