CTRI

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CTRI Number

CTRI/2025/05/086378 [Registered on: 06/05/2025] Trial Registered Prospectively

Last Modified On:

29/04/2025

Post Graduate Thesis

Type of Trial

PMS

Type of Study

Probiotic

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Clinical Study on AllerBio(R) for Allergic Rhinitis With or Without Asthma

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
MC/ALB/25-001 Version 1.0 dated 29 Jan 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sandeep V V
Designation	Marketing Manager
Affiliation	Fourrts (India) Laboratories Pvt. Ltd.
Address	Fourrts (India) Laboratories Pvt. Ltd. Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097 Chennai TAMIL NADU 600097 India
Phone	8148900689
Fax
Email	sandeepvv@fourrts.com

Details of Contact Person
Scientific Query

Name	Sandeep V V
Designation	Marketing Manager
Affiliation	Fourrts (India) Laboratories Pvt. Ltd.
Address	Fourrts (India) Laboratories Pvt. Ltd. Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097 Chennai TAMIL NADU 600097 India
Phone	8148900689
Fax
Email	sandeepvv@fourrts.com

Details of Contact Person
Public Query

Name	Sandeep V V
Designation	Marketing Manager
Affiliation	Fourrts (India) Laboratories Pvt. Ltd.
Address	Fourrts (India) Laboratories Pvt. Ltd. Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097 Chennai TAMIL NADU 600097 India
Phone	8148900689
Fax
Email	sandeepvv@fourrts.com

Source of Monetary or Material Support

Fourrts (India) Laboratories Pvt. Ltd. Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097

Primary Sponsor

Name	Fourrts (India) Laboratories Pvt. Ltd.
Address	Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 3
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Rajeev Kumar	All India Institute of Medical Sciences, Delhi	Department of ENT, Room No-4063, 4th Floor AIIMS, Ansari Nagar, Delhi New Delhi- 110029, India New Delhi DELHI	9968569892 rajeev9843@yahoo.co.in
Dr Amit Bikram Maiti	IPGME&R and SSKM Hospital	Department of ENT, Ground floor, Room No. 5 244, A.J.C. Bose Road, Kolkata 700 020 Kolkata WEST BENGAL	9433238889 amitent2004@gmail.com
Dr Vijay Warad	Sai Netralaya and Speciality Clinic	A2 Wing, First Floor, Room 102 Araneshwar Park Phase II, A2 Wing, First Floor/102, Araneshwar Pune - 411009 Pune MAHARASHTRA	9822436184 drvijaypwarad@gmail.com

Details of Ethics Committee

No of Ethics Committees= 3
Name of Committee	Approval Status
Institute Ethics Committee	Submittted/Under Review
IPGME&R and Research Oversight Committee	Submittted/Under Review
Supreme Independent Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J309\|\|Allergic rhinitis, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Standard of care	Standard of care
Intervention	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 - Oral with water, Dose - 1 capsule for adults or 1 sachet for children, Frequency - Once daily, Duration of treatment - 84 days

Inclusion Criteria

Age From	6.00 Month(s)
Age To	65.00 Year(s)
Gender	Both
Details	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-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 7. Willingness to provide written informed consent

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
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	Day 0, Day 28, Day 56, Day 84

Secondary Outcome

Outcome	TimePoints
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

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Post Marketing Surveillance

Date of First Enrollment (India)

15/05/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

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:

1. Subjects in the test arm will undergo treatment with standard of care along with AllerBio® probiotic capsule/sachet for 84 days

2. 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.