NTU 101乳酸菌粉辅助改善特应性皮炎的疗效临床试验
NTU 101 乳酸菌粉辅助改善特应性皮炎的功效 - 双盲、多中心随机、安慰剂对照临床试验
研究概览
详细说明
在测试产品开始前有大约 2 周的筛选期。 符合本试验条件的受试者按1:1的比例随机分配,服用试验组中的乳酸菌NTU 101或安慰剂,共治疗12周。 一次,在治疗后,测试医师评估了服用测试组 NTU 101 乳杆菌或安慰剂的受试者的安全性和有效性。
治疗期结束后,所有受试者均接受为期 2 周的停药随访期。
本研究将跟踪受试者在取样前后的情况,对特应性皮炎进行评分(Screen-Visit 4)、儿童皮肤科生活质量指数(Visit 1-Visit4)、以患者为导向的湿疹测量(Visit 1-Visit4),以评估受试者的严重程度疾病。
受试者在采集样本前后接受以下检测:全套血液检测、白细胞分类计数、血清生化检测(BUN、肌酐、GOT、GPT),采集外周血单个核细胞和粪便样本分析受试者的免疫功能和胃肠道微生物群。
研究类型
注册 (预期的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 根据Hanifin & Rajka特应性皮炎的诊断标准,筛选临床诊断为特应性皮炎且符合以下条件的患者:
- 年龄:6岁以上12岁以下儿童
- 中度特应性皮炎患者:SCORAD 指数 25 - 49.9(中度)。
- 特应性皮炎诊断超过 6 个月
排除标准:
免疫缺陷:
先天性免疫缺陷:根据《台湾原发性免疫缺陷病分类及现状》的分类原则,分为(1)细胞/T细胞免疫缺陷(2)体液免疫缺陷(Humoral/B-(3)补体缺陷(4)吞噬细胞缺乏症。
- 人类免疫缺陷病毒(Human Immunodeficiency Virus,HIV)感染(从病历中查询)。
- 其他影响免疫功能的疾病,包括肾病、糖尿病、肝硬化和慢性肝病、无脾等。
- 短肠综合症(短肠综合症)。
- 恶性肿瘤患者。
- 有中心静脉导管的患者。
- 继发性细菌感染。
- 在过去 3 个月内接受过免疫抑制剂和生物制剂(例如:dupilumab、Janus 激酶 (JAK) 抑制剂、Janus 激酶抑制剂)。
- 在过去 1 个月内接受过口服或注射类固醇、抗生素和光疗。
- 连续(3天或以上)服用中草药、益生菌补充剂或其他发酵食品,如酸奶、酸奶、养乐多。
- 肝或肾功能异常(高于正常值的 1.5 倍)。
- 其他皮肤病或其他全身性疾病。
- 近3个月参加过其他临床试验。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂胶囊
麦芽糖糊精用作安慰剂。
|
麦芽糖糊精被用作安慰剂
|
实验性的:Probiotic NTU 101 乳酸菌胶囊
符合本试验条件的受试者按1:1的比例随机分配,在试验组服用乳酸菌NTU 101(1.8 x 10 ^10 CFU)或Placebo共12周治疗。
一次,在治疗后,测试医师评估了服用测试组 NTU 101 乳杆菌的受试者的安全性和有效性。
|
每天一粒 NTU 101 乳酸菌植物胶囊,共 12 周。 产品成分:微晶纤维素、玉米淀粉、NTU 101 副干酪乳杆菌亚种。 副干酪 NTU 101(1.8 x 10^10 CFU);胶囊壳组成:HPMC(羟丙基甲基纤维素)、纯净水、二氧化钛、结冷胶。 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
特应性皮炎评分 (SCORAD) 改善总分
大体时间:12周
|
与安慰剂组相比,服用益生菌或安慰剂 4、8、12 周后,对照组特应性皮炎严重程度评分 SCORAD 改善至少 30% 或试验组受试者与安慰剂组的比例 安慰剂组根据统计方法,SCORAD提高总分有统计学差异,至少达到两项中的一项。
|
12周
|
合作者和调查者
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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