NCT06104917已完成3 期
Effect of MaolactinTM Supplement on Gastrointestinal Tract (GIT) Health in Adult Subjects: a Double-blind Randomized Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in upper gastrointestinal symptoms
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 3 arm parallel group study of 12 weeks duration, with a 4-week run-in period as the control phase and an 8-week intervention period, to investigate the effectiveness of the treatment on upper GI disturbance.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and over
- •Generally healthy
- •BMI <35kg/m2
- •Able to provide informed consent
- •Agree to not participate in another clinical trial while enrolled in this trial
- •Females using a prescribed form of birth control (e.g. oral contraceptive)
- •Experiencing moderate GI disturbances of the upper GI tract - 1 or multiple symptoms (reflux, heartburn, regurgitation, nausea, bloating, abdominal pain) at least once a week for at least 3 months.
- •Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2-month period of self-reported dietary stability.
- •Agree to not change current diet and/or exercise frequency or intensity during entire study period
- •Agree to not use any dietary supplements for gut health or digestive enzymes during the study period
排除标准
- •Unstable(1) or serious illness (e.g. serious mood disorders such as depression or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)
- •People with a past or current history of GIT conditions e.g. inflammatory bowel disease, celiac disease or cystic fibrosis as well as gastrointestinal tract surgery
- •Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- •Currently taking any proton pump inhibitors [e.g., pantoprazole (Somac), rabeprazole (Pariet), omeprazole (Losec) or any anticoagulation or antiplatelet medications [e.g. Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin, dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), betrixaban (Bevyxxa), clopidogrel (Plavix), prasugrel (Effient), ticagrelor (Brilinta), cilostazol (Pletal) and dipyridamole (Attia, Ofcram, Persantin, Persantin Retard, Trolactin)] including low dose aspirin (acetylsalicylic acid)
- •Active smokers, nicotine use or drug (prescription or illegal substances) abuse
- •Allergic to any of the ingredients in active or placebo formula
- •Pregnant or lactating woman or women trying to conceive
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion (including hypercholesterolemia)
- •Currently participating in any other clinical trial
- •(1)An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
研究组 & 干预措施
High Dose Maolactin
Experimental
Maolactin 500mg per day - 2 capsules containing 250mg active proteins per capsule; equivalent to 500mg active proteins per day
干预措施: High Dose Maolactin (Drug)
Low Dose Maolactin
Experimental
Maolactin 250mg per day - 1 capsule containing 250mg active proteins per capsule and 1 capsule containing maltodextrin only; equivalent to 250mg active proteins per day
干预措施: Low Dose Maolactin (Drug)
Maltodextrin
Placebo Comparator
Placebo capsule - 2 capsules containing Maltodextrin per day
干预措施: Maltodextrin (Drug)
结局指标
主要结局
Change in upper gastrointestinal symptoms
时间窗: Day -28, Day 0, Day 14, Day 28, Day 56
Change in upper gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS)
次要结局
- Change in upper gastrointestinal symptoms(Day -28, Day 0, Day 14, Day 28, Day 56)
- Change in diet(Days -27, -26, -25, Days -3, -2, -1, Days 25, 26, 27, Days 53, 54, 55)
- Change in gut microbiome(Day 0, Day 56)
- Change in stool frequency and consistency(Day -28, Day 0, Day 14, Day 28, Day 56)
- Change in safety(Day -28 to Day 56)
- Change in gut inflammation(Day 0, Day 56)
- Change in quality of life(Day -28, Day 0, Day 14, Day 28, Day 56)
- Change in intestinal permeability(Day 0, Day 56)
- Change in inflammatory markers(Day 0, Day 56)
研究者
研究点 (1)
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