Comparative Effects of A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children: a Double-blinded Randomized Controlled Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Change from baseline of gastrointestinal symptom VAS scores
研究概览
简要总结
This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.
详细描述
Gut inflammation is reflected by serum C-Reactive Protein (CRP), hemoglobin (HB), interleukin-4 (IL-4), Immunoglobulin G (IgG), Immunoglobulin E (IgE), Immunoglobulin G1 (IgG1), Immunoglobulin G2a (IgG2a), β-Casomorphin-7 (BCM-7), Glutathione, calcium (Ca), iron (Fe) and zinc (Zn) concentration; gastrointestinal (GI) symptoms are measured via Visual Analog Scale (VAS) for gut tolerance, including borborygmus, bloating, break wind, abdominal pain, and diarrhea; behavioral well-being is assessed using Subtle Cognitive Impairment Test (SCIT).
The total duration of study was 24 weeks, including subject enrollment, study intervention, laboratory testing, and providing clinical study report. The cross-over study consisted of 5 days of each product intervention; 10 days of wash-out in phase 1 and phase 2, respectively; and then followed by 6 weeks of statistical analysis and clinical report completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-regular milk drinker;
- •Suffered from mild to moderate milk intolerance;
- •Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
- •Parent(s) or legal guardian's consent to the study and willing to comply with study procedures;
- •Parent(s) or guardian of infant agrees not to enroll infant another clinical study while participating in this study;
- •Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
排除标准
- •Have known dairy allergy;
- •Suffered from severe milk intolerance;
- •Unable to give written informed consent;
- •Use of antibiotics at the time of screening, or during the past two weeks;
- •Have history of fecal impaction;
- •Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months;
- •Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
- •Currently taking medicines for cardiovascular or metabolic disease;
- •Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
- •Currently suffering from any gastrointestinal disorders or gastrointestinal disease , including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome (IBS);
- •Had hospitalizations within 3 months before screening;
- •According to investigator's judgment, current frequent users of drugs may affect the gastrointestinal function or immune system.
结局指标
主要结局
Change from baseline of gastrointestinal symptom VAS scores
时间窗: Baseline (day 1 for phase 1 and day 15 for phase 2, before product consumption), at the end of the 5-day product consumption (day 5 for phase 1 and day 19 for phase 2)
were self-measured by study subjects on a scale from 0 (never) to 3 (always) at baseline (day 1 for phase 1 and day 15 for phase 2, before product consumption) and at the end of the 5-day product consumption (day 5 for phase 1 and day 19 for phase 2).
次要结局
- Stool frequency(Day -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- Stool consistency(Day -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, 10, 11, 12, 13, 14, 5, 16, 17, 18, 19)
- Serum C-reactive protein (CRP) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Hemoglobin (HGB) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Interleukin-4 (IL-4) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Immunoglobulin G (IgG) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Immunoglobulin E (IgE) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Immunoglobulin G1 (IgG1) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Immunoglobulin G2a (IgG2a) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum β-Casomorphin-7 (BCM-7) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum Glutathione concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum calcium (Ca) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum iron (Fe) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Serum zinc (Zn) concentration(Day 1 before intervention (baseline), and day 5 (post-intervention))
- Fecal short chain fatty acids (SCFA) concentration(Day 1, Day 5, Day 15, Day 19)
- myeloperoxidase (MPO)(Day 1, Day 5, Day 15, Day 19)
- Subtle Cognitive Impairment Test (SCIT)(16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 1; 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 5; 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 15; 16, 32, 48, 64, 80, 96, 112 and 128 millisecond on day 19)