Study of the Probiotic Potential of a Lacticaseibacillus Strain in the Upper Airways in Patients With Allergic Rhinoconjunctivitis After Administration in a Chewable
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
研究概览
简要总结
With this double- blind, randomised, placebo-controlled study, the investigators want to investigate the influence of a chewable with the probiotic strain Lacticaseibacillus rhamnosus GG on the symptoms and immunological markers of allergic rhinoconjunctivitis (AR). In addition, the investigators aim to study the influence of this probiotic chewable on the microbiome of the upper respiratory tract after administration in adults with AR. The bacterial and cytokine profiles in the naso- and oropharynx will be monitored before, during and after the treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 at the time of registration;
- •Seasonal allergic rhinoconjunctivitis (AR) in the context of grass pollen allergy diagnosed on the basis of anamnesis cfr. ARIA guidelines and positive skin prick test and / or immunocap assay;
- •Positive skin prick test (SPT) for grass pollen and / or the presence of specific IgE for grass pollen, confirmed by a medical specialist, measured at the start of the study: Soluprick SQ Phleum pratense pollen 10 HEP - ALK and / or IgE specific immunocap assay Phleum pratense (timothy grass) (g6);
- •Body Mass Index in the range of 19-32 kg / m2;
- •Instructed during screening and agreed not to use other probiotic products outside of the study during the study period;
- •Signed the consent form.
排除标准
- •Antibiotic use at baseline and during the study;
- •Pregnant women;
- •Unstable / uncontrolled asthma (to be determined by investigator-physician);
- •Sensitization to dust mites
- •History of probiotic use in the past two weeks;
- •Current diagnosis of cancer or immunosuppressive therapy within the past 6 months;
- •Abnormalities of the oral mucosa;
- •Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis cfr. EPOS guidelines);
- •Clinically significant bleeding disorder;
- •Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial;
- •History of regular use (> 3 days out of 7) of tobacco products within the previous two weeks
结局指标
主要结局
Transfer of L. rhamnosus GG (estimated CFU counts) to the oronasopharyngeal cavity after administration of the chewable
时间窗: at 8 weeks
qPCR
Changes in the score of allergic rhinitis symptoms
时间窗: over the study period (= 10 weeks)
Daily questionnaires will be used, in which a self-reported Total Nasal Symptom Score (TNSS) based on rhinorrhea, nasal congestion, nasal itching and sneezing with symptom severity ranging from 0 (no problem) to 12 (very severe problem) will be recorded.
次要结局
- changes in microbiome of the oronasopharyngeal region after administration of the chewable(baseline, 8 weeks)
- Inlfuence on general nose- and mouth health(baseline, 8 weeks, 10 weeks)
- Changes in the absolute numbers of specific airway pathogens and viruses(baseline, 8 weeks)
- Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in oro- and nasopharynx samples, and cytokine and antibody levels in blood samples(baseline, 8 weeks)
- Frequency of medication use(over the study period (= 10 weeks))
研究者
Sarah Lebeer
Prof. dr.ir.
University Hospital, Antwerp