The Effect of Polyvalent Mechanical Bacterial Lysate on the Reduction of Nasal Staphylococcus Aureus Carriage in Children With Pollen Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in the growth intensity of the nasal Staphylococcus aureus colony
研究概览
简要总结
This study assesses the effectiveness of Polyvalent Mechanical Bacterial Lysate (PMBL-Ismigen) in reducing nasal methicillin-resistant Staphylococcus aureus (MRSA) colony growth in children with pollen allergic rhinitis (AR) aged 5 to 17. Half of the participants received PMBL and the other half received a placebo.
详细描述
Seasonal allergic rhinitis (SAR) is caused by the allergens of wind-pollinated plants, and in Poland mainly by grass pollen allergens. During the grass pollen season, patients may suffer from fatigue, weakness, lack of fitness, difficulty in sleeping and reduced performance at school. In people allergic to the above-mentioned pollen, the disease significantly reduces the quality of life and requires intensive treatment in the pollen period.
MRSA colonizing the nasal cavity has the ability to actively modulate the immune response in children suffering from SAR. Many studies have shown a greater severity of AR symptoms in patients with a MRSA-positive nasal swab compared to patients with normal nasal flora.
Due to the high incidence of AR, the negative impact of the disease on the quality of life, and incomplete effectiveness of previously available therapeutic methods, new methods of treatment are being developed. Recent research highlights the immunoregulatory potential of bacterial lysates, indicating the possibility of their future use in the prevention and treatment of allergic diseases, including atopic dermatitis, AR, and asthma.
Based on the above considerations, it can be hypothesized that bacterial lysates reduce the severity of AR symptoms by eradicating MRSA from the nasal cavity. However, so far no randomized, double-blind, placebo-controlled study has been conducted to evaluate the effect of bacterial lysates on nasal Staphylococcus aureus carriage in children with SAR.
The main aim of this study was to evaluate nasal colonization by MRSA among children with SAR and the effect of PMBL on the reduction of MRSA colony growth in these children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both genders aged 5 to 17 years.
- •Children with grass pollen-induced allergic rhinitis recognized and treated according to current ARIA (Allergic Rhinitis and its Impact on Asthma) recommendations.
- •Positive skin prick test to grass pollen allergens or positive specific IgE (defined as ≥ class 2, ≥ 0,70 kU/l) against timothy grass pollen allergens.
- •Presentation of clinical symptoms of the allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing) in at least two recent grass pollen seasons in Poland before inclusion in the study.
- •Proper use of polyvalent mechanical bacterial lysate sublingual tablets.
- •Written informed consent obtained from parents/guardians before any study related procedures are performed.
排除标准
- •Patient received mechanical or any other polyvalent bacterial lysate immunostimulation within the previous 12 months before randomisation visit.
- •Patient received oral/subcutaneous allergen-immunotherapy within the previous 3 years before the start of the study.
- •Vaccination performed within 3 months before the beginning of the study.
- •Deficiencies in cellular and humoral immunity.
- •Treatment with antibiotics within the last 1 month before the start of the study.
- •Treatment with systemic corticosteroids within the last 6 months before the start of the study.
- •Pregnant or breastfeeding woman.
- •Other chronic conditions of the nose or nasal sinuses.
研究组 & 干预措施
Ismigen
Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.
干预措施: Ismigen (Drug)
Placebo
Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the growth intensity of the nasal Staphylococcus aureus colony
时间窗: at baseline, and at 3-months
At the randomization visit and end-of-study visit, a nasal swab was collected for bacteriological cultures and compared whether there was a change in the growth intensity of the Staphylococcus aureus colony between these two points. The collected material was placed in a test-tube with a transport medium and transferred to the laboratory of the University Children's Hospital in Lublin, where it was inoculated on appropriate media. Microbial growth was assessed by semi-quantitative method (+ scanty growth, ++ moderate growth, +++ large growth, ++++ abundant growth).
次要结局
- Incidence of treatment emergent adverse events [safety and tolerability](from baseline, up to the 3-month time point)
- Incidence of treatment emergent adverse events leading to discontinuation [safety and tolerability](from baseline, up to the 3-month time point)
- Time to discontinuation due to treatment emergent adverse events [safety and tolerability](From date of randomization until the date of occurrence of an adverse event leading to discontinuation, assessed up to 3 months)
- Incidence of treatment emergent abnormalities in physical examination findings [safety and tolerability](at baseline, and at 3-months)
- Incidence of treatment emergent abnormalities in pulse rate [safety and tolerability](at baseline, and at 3-months)
- Incidence of treatment emergent abnormalities in blood pressure [safety and tolerability](at baseline, and at 3-months)
研究者
Kamil Janeczek
Principal Investigator
Medical University of Lublin