Efficacy of L. paracasei GMNL-133 and L. fermentum GM-090 (AllerBio(R)) in Allergic Rhinitis (with or without Asthma): An Open-Label Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- To compare the efficacy of L. paracasei GMNL-133 and L. fermentum GM-090 along with standard of care versus standard of care alone in symptom alleviation of allergic rhinitis (and asthma, if applicable) and reduction of serum IgE levels
研究概览
简要总结
It is an Open-label, multicentric, randomized controlled trial on Allergic rhinitis (with or without asthma). After obtaining written approval from institutional ethics committees of the study sites, written informed consent/ assent (as applicable) will be obtained from male or female patients aged between 6 months to 65 years. If all eligibility criteria are satisfied, patients will be enrolled in the study, and details such as demographic data, medical history/comorbidities, and prior medications will be recorded at baseline.
Enrolled subjects will be randomized into two arms:
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Subjects in the test arm will undergo treatment with standard of care along with AllerBio® probiotic capsule/sachet for 84 days
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Subjects in the reference arm will undergo treatment with standard of care.
Telephonic visits are scheduled at Day 28 days and Day 56 days. An in-person visit after baseline is scheduled at the end of study participation at Day 84 days.
During in-person visits, physical examination and examination of vital signs will be done along with recording of AEs, concomitant medications, and treatment compliance. Additionally, subjects will be required to record their responses to the following questionnaires: Instant Total Nasal Symptom Scores (iTNSS) and Rhinoconjunctivitis Quality of Life Questionnaire. Serum IgE levels will be measured at baseline and at Day 84 days.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged between 6 months to 65 years
- •Clinical diagnosis of allergic rhinitis (with or without asthma, as per Investigator) based on presence of at least 2 of the following symptoms: runny nose, nasal congestion, sneezing, nasal itching
- •Mild or moderate-severe allergic rhinitis, where mild refers to absence of the following and moderate-severe refers to presence of one or more of the following: Sleep disturbance Impairment of daily activities, leisure, and or sport Impairment of school or work Troublesome symptoms
- •Intermittent (less than 4 days per week or for less than 4 consecutive weeks) or persistent (greater than or equal to 4 days per week and for greater than or equal to 4 consecutive weeks) symptoms of allergic rhinitis
- •Instant Total Nasal Symptom Score (iTNSS) greater than or equal to 5 at baseline
- •Treatment-naïve for the current episode of allergic rhinitis, that is, not received any medication for the current episode of allergic rhinitis within 14 days prior to screening
- •Willingness to provide written informed consent.
排除标准
- •Asymptomatic with high IgE at baseline.
- •as per investigator judgement
- •Diagnosis of sinusitis or conjunctivitis in the current episode of allergic rhinitis, based on investigator judgement
- •Requirement of hospitalization at baseline
- •Consumption of any probiotic preparation (including the study medication) within 4 weeks prior to screening
- •Received immunosuppressants, antibiotics, systemic corticosteroids, or antimycotics within 4 weeks prior to screening
- •Received antihistamines within 3 days prior to screening
- •Consumption of any other medication, that, in the opinion of the investigator, could confound the results of the current trial
- •Requirement of decongestants (nasal, oral, or ocular), nasal topical antihistamines, or steroids for any medical condition
- •Known allergy, hypersensitivity, proven inefficiency, or contraindications to the study medication, any of its excipients, or products containing any of the excipients
- •Clinically significant nasal structural abnormalities or obstruction, nasal polyps, marked septum deviation or septal perforation or recent nasal surgery, based on historical (less than 5 years) medical reports
- •Current or history (ie, within 12 months prior to screening) of alcohol, drug, or medication abuse (as per Investigator judgement)
- •Known immunodeficiency or malignancy, that, in the opinion of the investigator, could interfere with the patient’s participation or compliance in the study
- •Known diagnosis of urticaria, vasomotor rhinitis, rhinitis medicamentosa
- •Known cardiovascular, endocrine, hepatic, renal, pulmonary, respiratory, or hematological abnormalities, that, in the opinion of the investigator, could interfere with the patient’s participation or compliance in the study
- •Recent or planned major surgery, that, in the opinion of the investigator, could interfere with the patient’s participation
- •Pregnant or breastfeeding women, or women of child-bearing potential not in agreement to use adequate birth control methods throughout the study
- •Participation in another clinical trial concurrently or within 30 days prior to screening
- •Planned participation in any other trial during the entire duration of the study
- •Refusal or inability to comply with the requirements of the protocol for any reason, including in-person visits and answering questionnaires
- •Any other condition in the patient which, in the opinion of the Investigator, could confound the results of the trial, put the patient at undue risk, or make the patient unsuitable for participation.
结局指标
主要结局
To compare the efficacy of L. paracasei GMNL-133 and L. fermentum GM-090 along with standard of care versus standard of care alone in symptom alleviation of allergic rhinitis (and asthma, if applicable) and reduction of serum IgE levels
时间窗: Day 0, Day 28, Day 56, Day 84
次要结局
- To compare the safety and quality of life achieved by L. paracasei GMNL-133 and L. fermentum GM-090 administration with standard(Day 0, Day 28, Day 56, Day 84)