Efficacy of Oral Supplementation of Probiotics in Children With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of participants in each sex group
研究概览
简要总结
Various clinical studies have evaluated the role of probiotics in children with atopic dermatitis, with some studies showing improvement in clinical outcome after supplementation of probiotics and others showing no additional benefit. This study is to provide clinical evidence of effect of a mixture of probiotics in Atopic Dermatitis (AD) patients based on improvement in SCORAD (SCORing Atopic Dermatitis) index.
详细描述
Atopic dermatitis (AD) is the common chronic inflammatory skin disease with relapsing courses that often start in infancy and childhood. It is characterized by erythema, itchy papules, occasionally vesicles (in infants), which may become excoriated and lichenified and have a typical flexural distribution. Atopy is defined as a "personal or familial tendency to produce immunoglobulin antibodies in response to even low doses of allergen, and associated with development of AD, asthma and rhinoconjunctivitis.The worldwide prevalence of AD is estimated to be 20% in children and 2-10% in adults. The incidence of AD has increased by 2 to 3 folds in past 3 decades in the industrialized countries and represents a major public health burden. According to the International Study of Asthma and Allergies in Childhood (ISAAC) phase 3, the prevalence of AD among the age group of 13 to 14 in Africa and Latin America was at 12-14% and 6-10% respectively. The Asian Pacific countries, the Eastern Mediterranean region and the Indian subcontinent, it was 3-6% among the same age groups (13-14 years). Whereas among 6 to 7 years children, for Asian Pacific countries, Africa and Latin America the prevalence of AD was around 10% and in Indian subcontinent and Eastern Mediterranean region, value was lower at 3-5%
In Nepal the frequency of AD in all age group was 2% as per a year hospital based study done by Singh S and Agrawal S et.al in 2012. (Unpublished data, on personal communication)
The pathogenesis of AD appears to result from interaction between various genetic and environmental factors. It is associated with skin barrier dysfunction and immune dysregulation. The barrier dysfunction is early feature of AD which may be a primary but may also be a secondary to skin inflammation. Lack of exposure to microbial stimuli in early life programs the immune system towards Th2-type allergic response as described by 'hygiene hypothesis'.In allergic disorders there is shift of the Th1/Th2 cytokine balance towards a Th2 response, and causes the release of Interleukin-4, interleukin-5 and interleukin-13 as well as Immunoglobulin E production.
The diagnosis of AD is mainly clinical as there is no specific test for AD. Diagnosis of AD is based on specific a criterion which includes patient's history, clinical presentations as well as family history. In 1980 Hanifin and Rajka proposed major and minor diagnostic criteria based on clinical symptoms of AD. Williams coordinated a UK working party to attempt to simplify and refine the criteria given by Hanifin and Rajka in 1994. Severity of disease is evaluated by using widely accepted SCORing Atopic Dermatitis (SCORAD), based on extent of area involved, severity of symptoms and intensity of the subjective symptoms of pruritus and sleep disturbances.The chronic and recurrent nature of AD negatively impacts the quality of life (QOL) of patients as well as their family members. The symptoms of AD limit patient's physical, psychosocial development and quality of sleep.
The main goals of treatment are to improve the skin barrier function and hydration, to suppress inflammation and to control microbial colonization. It can be achieved through emollients, topical corticosteroids and topical calcineurin inhibitor like tacrolimus. Oral drugs like corticosteroids, methotrexate and cyclosporine are reserved for severe cases.
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
- Single (Outcomes Assessor)
盲法说明
In this study, there will be three investigators i.e, one principal investigator, and two co-investigators. Among them, one of the co-investigators will be blinded who will act as an assessor.
入排标准
- 年龄范围
- 4 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a diagnosis of atopic dermatitis that meet Hanifin and Rajka criteria
- •SCORAD ( SCORing Atopic Dermatitis) index 15- 50 at the time of enrollment
排除标准
- •SCORAD (SCORing Atopic Dermatitis) index <15 or >
- •Children treated with systemic corticosteroids, methotrexate, or cyclosporine in the previous 3 months and antibiotics in the previous 2 weeks.
- •Immunocompromised children.
- •Concomitant diagnosis of intolerance to gluten and/ or lactose.
- •Pre-existing hypersensitivity to components contained in the probiotics.
- •Children suffering from chronic infectious diseases.
- •A child with other known systemic diseases (heart, liver or kidney diseases).
- •Known case of short gut syndrome.
- •Refusal of children's parents to participate in the study.
研究组 & 干预措施
Group A (Interventional group)
Along with below mentioned conventional treatment, the participants in group A (i.e. Interventional group) will receive conventional treatment of AD for a short duration along with probiotics for 8 weeks. One probiotic sachet twice a day will be prescribed. A sachet of 2 grams containing 1.25 billion cells per gram of 4 strains (Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii) will be used. The child will receive a total of 5 billion cells of probiotics per day.
干预措施: Probiotic sachet containing mixture of four strains i.e.Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii (Drug)
Group A (Interventional group)
Along with below mentioned conventional treatment, the participants in group A (i.e. Interventional group) will receive conventional treatment of AD for a short duration along with probiotics for 8 weeks. One probiotic sachet twice a day will be prescribed. A sachet of 2 grams containing 1.25 billion cells per gram of 4 strains (Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii) will be used. The child will receive a total of 5 billion cells of probiotics per day.
干预措施: Conventional treatment (Drug)
Group B (Conventional group)
All patients (i.e. in both arms) with atopic dermatitis will be prescribed emollients and cleanser as a part of routine skin care. Topical corticosteroid (i.e. Fluticasone 0.05% cream) and topical calcineurin inhibitor (tacrolimus 0.1% ointment) for sensitive areas like periorbital regions, flexures and face, will be given once daily. All patients will be given an oral antihistamine (syrup/ tablet cetirizine 0.3mg/kg) at night. It is referred to as conventional treatment.
干预措施: Conventional treatment (Drug)
结局指标
主要结局
Number of participants in each sex group
时间窗: At the time of enrollment
Sex distribution of Atopic Dermatitis patients in male, female or others group
Duration
时间窗: At the time of enrollment
Duration of Atopic Dermatitis
Change in SCORing Atopic Dermatitis (SCORAD) index
时间窗: Enrollment, 4 weeks, 8 weeks, 10 weeks and 12 weeks of treatment
Based on three aspects, extent of disease, disease severity and subjective symptoms combine to give a maximum possible score of 103.
History Of Atopy
时间窗: Enrollment
Personal or Family history of atopy
次要结局
- Number of participants who had taken past treatment(Enrollment)
- Age of Onset(Enrollment)
- Number of participants having each of systemic illnesses(Enrollment)
- Change in Family Dermatology Life Quality Index(At the time of enrollment and at 8 weeks of commencing treatment.)
研究者
Kamala Acharya
Junior Resident, Department of Dermatology and Venereology
B.P. Koirala Institute of Health Sciences
