Open label, Multicentric, Comparative, RandomizedClinical Study to Evaluate the Safety and Efficacy ofOral administration of Tep-AD® (probioticLactobacillus salivarius) in Indian Children having byModerate and Severe Atopic Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- To evaluate the efficacy of Tep-AD® (probiotic formulation containing Lactobacillus salivarius-2×10â¹
研究概览
简要总结
Atopic dermatitis (AD) is a chronic inflammatory skin disease with
multifactorial etiopathology, which is most prevalent in childhood.
Normally, childhood AD appears in the first 5 years of life, with about 60%
of cases appearing between 0 and 6 months. The decreased microbial
exposure due to urbanization, the intensive use of antibiotics and vaccines,
and improved infant sanitation lead to the increased development of AD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female children between 0-11 years of age (both inclusive) Suffering from moderate or severe atopic dermatitis.
- •Children and parents / guardians who agree to comply with study requirement and schedule.
- •Parents or legal guardians willing to sign written informed consent form for the child and child willing to sign assent form for participation (if old enough to understand his /her participation in study).
排除标准
- •Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study.
- •Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study.
- •Subjects with any other chronic illness such as acute asthma, heart blocks, any congenital anomaly.
- •Subjects with chronic and infectious diseases.
- •Subjects with hypersensitivity to any components contained in the probiotic sachets.
- •Inability to keep return appointments.
- •Participated in any clinical investigation in the last 30 days.
- •Not found suitable as per discretion of investigator.
结局指标
主要结局
To evaluate the efficacy of Tep-AD® (probiotic formulation containing Lactobacillus salivarius-2×10â¹
时间窗: Timepoints will be assessed in all visits.
CFU/sachet) when administered orally for the treatment of moderate and severe atopic dermatitis (AD)
时间窗: Timepoints will be assessed in all visits.
in children using:
时间窗: Timepoints will be assessed in all visits.
i. Objective SCORAD / SCORAD index
时间窗: Timepoints will be assessed in all visits.
ii. Itch index
时间窗: Timepoints will be assessed in all visits.
次要结局
- Patient reported outcomes of worsening of any baseline symptoms evaluated at every visit until(post treatment follow-up visit.)