Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: Standard of care along with AllerBio(R) probiotic (2 billion heat-killed cells each of Lactobacillus paracasei GMNL-133 and Lactobacillus fermentum GM-090): Route of administration - Or
Sponsors
Fourrts (India) Laboratories Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 6 months to 65 years 2. 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 3. 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 4. 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 5. Instant Total Nasal Symptom Score (iTNSS) greater than or equal to 5 at baseline 6. Treatment-na ve 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 7. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Asymptomatic with high IgE at baseline - as per investigator judgement 2. Diagnosis of sinusitis or conjunctivitis in the current episode of allergic rhinitis, based on investigator judgement 3. Requirement of hospitalization at baseline 4. Consumption of any probiotic preparation (including the study medication) within 4 weeks prior to screening 5. Received immunosuppressants, antibiotics, systemic corticosteroids, or antimycotics within 4 weeks prior to screening 6. Received antihistamines within 3 days prior to screening 7. Consumption of any other medication, that, in the opinion of the investigator, could confound the results of the current trial 8. Requirement of decongestants (nasal, oral, or ocular), nasal topical antihistamines, or steroids for any medical condition 9. Known allergy, hypersensitivity, proven inefficiency, or contraindications to the study medication, any of its excipients, or products containing any of the excipients 10. 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 11. Current or history (ie, within 12 months prior to screening) of alcohol, drug, or medication abuse (as per Investigator judgement) 12. Known immunodeficiency or malignancy, that, in the opinion of the investigator, could interfere with the patient s participation or compliance in the study 13. Known diagnosis of urticaria, vasomotor rhinitis, rhinitis medicamentosa 14. 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 15. Recent or planned major surgery, that, in the opinion of the investigator, could interfere with the patient s participation 16. Pregnant or breastfeeding women, or women of child-bearing potential not in agreement to use adequate birth control methods throughout the study 17. Participation in another clinical trial concurrently or within 30 days prior to screening 18. Planned participation in any other trial during the entire duration of the study 19. Refusal or inability to comply with the requirements of the protocol for any reason, including in-person visits and answering questionnaires 20. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 levelsTimepoint: Day 0, Day 28, Day 56, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety and quality of life achieved by L. paracasei GMNL-133 and L. fermentum GM-090 administration with standardTimepoint: Day 0, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactSandeep V V
Fourrts (India) Laboratories Pvt. Ltd.
Outcome results
None listed