A Non-Randomized, Open-Label Trial of the Efficacy of Treatment for Helicobacter Pylori Infection in Preschooler by Yoghurt With LG21
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- H. pylori-negative conversion rate and the levels of H. pylori antigen measured and confirmed through fecal H. pylori antigen tests at each visit.
研究概览
简要总结
The goal of this non-randomized, open-label, interventional trial is to study the efficacy of treatment for Helicobacter Pylori Infection in Preschooler aged 4-6 by Meiji Yoghurt with LG21. The main question it aims to answer is:
- whether the treatment by Meiji Yoghurt LG21 is effective by stool antigen (HpSA) test
140 qualified participants will be enrolled and non-randomized into 2 groups of the same size (product study group and blank control group). Participants of the product study group will need to eat assigned Meiji Yoghurt for 12 weeks, one bottle each day, while participants of the blank control group won't receive any intervention during the study. Four visits will be made for all participants, and relevant clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis and reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschooler aged 4-6 years
- •H. pylori positive
- •Drink milk or milk beverages regularly (more than three times a week) before joining the study
- •ICF signed
- •Parents or guardians agree not to participate in other interventional clinical studies during this study
排除标准
- •Has potential metabolic class or chronic disease
- •Use of antibiotics within 7 days before allocation (as judged by the trial responsible physician)
- •People who have been treated for eradication of Helicobacter pylori
- •Pharmaceuticals, medicinal skin care products (medical external products) and health foods that may affect gastric symptoms have been commonly used since more than one month ago
- •Already under digestive system treatment
- •Has lactose intolerance or protein allergy
- •Those whose families had plans to leave Jinhua City during the study period
- •Fails to comply with the provisions of the protocol
- •Those who are deemed unsuitable as subjects by the physician
研究组 & 干预措施
Meiji Yogurt Group
Meiji LG21 yogurt: 180 g/bottle, main ingredients:
Raw milk, water, sugar, skim milk powder, food additives (hydroxypropyl distarch phosphate, pectin), cream, whey protein powder, food flavor, Lactobacillus paragasseri, Lactobacillus bulgaricus, Streptococcus thermophilus.
干预措施: Meiji Yogurt Group (Dietary Supplement)
Blank Control Group
No interventional product for this arm
结局指标
主要结局
H. pylori-negative conversion rate and the levels of H. pylori antigen measured and confirmed through fecal H. pylori antigen tests at each visit.
时间窗: baseline day 0, day 42, day 84, day 112
The stool of the participants will be assessed by Helicobacter pylori Stool Antigen Test (HpSA) on baseline day 0, day 42, day 84, and day 112. A negative result indicates that participant is infection-free.
次要结局
- Gastrointestinal symptom scores(baseline day 0, day 42, day 84, day 112)
- Stool frequency score (using the Bristol stool scale)(baseline day 0, day 42, day 84, day 112)
- Stool consistency (using the Bristol stool scale)(baseline day 0, day 42, day 84, day 112)
- The problem behavior scores (using the Child Behavior Checklist, CBCL)(baseline day 0, day 84)
- Salivary amylase and cortisol levels(baseline day 0, day 84)