| CTRI Number |
CTRI/2020/09/027657 [Registered on: 08/09/2020] Trial Registered Prospectively |
| Last Modified On: |
12/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate efficacy and safety of probiotics as immunomodulators in acute allergic rhinitis. |
|
Scientific Title of Study
|
A Prospective, Interventional, Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii 088AE, ImmunoSEB and a combination of Bacillus clausii 088AE plus Bacillus coagulans LBSC plus Bacillus subtilis PLSSC as immunomodulators in Acute Allergic Rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana Murthy |
| Designation |
Consultant MD in internal medicine |
| Affiliation |
Vagus Super Speciality Hospital |
| Address |
Department of internal medicine, 18th cross margosa road malleshwaram.
Bangalore
KARNATAKA
560003
India |
| Phone |
7259214727 |
| Fax |
|
| Email |
meggydoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjit Maity |
| Designation |
Team leader |
| Affiliation |
Advanced Enzyme Technologies Ltd |
| Address |
Plot No. A-135, Road No. 23
Wagle Industrial Estate
Near Spraytech Circle,
Thane 400604, Maharashtra, India
Thane
MAHARASHTRA
400604
India |
| Phone |
022-25830284 |
| Fax |
|
| Email |
chiranjit@advancedenzymes.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
2nd Main Road, Building #06, 3rd Floor. Arekere, Sarvobhogam nagar
Bangalore
KARNATAKA
560076
India |
| Phone |
918049788118 |
| Fax |
|
| Email |
subham@syncorp.in |
|
|
Source of Monetary or Material Support
|
| Advanced Enzyme Technologies Ltd |
|
|
Primary Sponsor
|
| Name |
Advanced Enzyme Technologies Ltd |
| Address |
Plot No. A-135, Road No. 23
Wagle Industrial Estate
Near Spraytech Circle,
Thane 400604, Maharashtra, India
|
| Type of Sponsor |
Other [Enzyme and probiotic manufacturing company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghana Murthy |
Vagus Super Speciality Hospital |
Department of internal medicine, 18th cross margosa road malleshwaram.
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J308||Other allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus clausii088AE |
Probiotic
Dosage Regimen: 2 Billion per gram per sachet, Twice a day (Morning and evening) for 4 weeks |
| Intervention |
combination of Bacillus clausii 088AE, Bacillus coagulans LBSC, Bacillus subtilis PLSSC |
Probiotic
Dosage Regimen: 6 Billion per gram per sachet, Twice a day (Morning and evening) for 4 weeks |
| Intervention |
ImmunoSEB |
Enzyme formulation
Dosage Regimen: 500 mg/capsule, 2 capsules Twice a day for 4 weeks |
| Comparator Agent |
Placebo |
Maltodextrin
Dosage Regimen:
1 sachet of Maltodextrin (1 g per sachet) Twice a day (morning and evening) Capsule: 2 capsules of Maltodextrin (1 g per capsule) Twice a day (morning and evening) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who have given written informed consent to participate in the study.
2. Subjects of either sex aged between 18 to 65 years (both inclusive) with acute allergic rhinitis.
3. At the time of the enrolment subject should have an investigator assessed:
A. Total Four Nasal Symptom Score of 4 -10 (both inclusive) with minimum nasal stiffness score of 2.
B. Total Two Ocular Symptom Score of 1 – 5 (both inclusive)
C. Cough with a score of 0-1 in a 4-point scale. |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of hypersensitivity to antihistamines or any of the excipients of study formulations.
2. Subjects with nasal structural abnormalities (including deviated nasal septum, nasal polyps etc.)
3. Subjects using nasal sprays or with nasal, ocular, sinus surgery in past 6 months.
4. Subjects with history of disorders of nasolacrimal drainage.
5. Subjects with rhinitis medicamentosa (defined as a condition characterized by nasal congestion without rhinorrhoea or sneezing that is triggered by the use of topical nasal decongestants for more than 4-6 days).
6. Subjects receiving immunotherapy for at least 6 months prior to enrollment in this study.
7. Subjects who have received intranasal/systemic corticosteroids in the past 4 weeks or cromolyn sodium in the last 2 weeks or are having any antibiotic therapy.
8. Subjects who would be requiring concomitant chronic or intermittent use of oral, intravenous, intramuscular, topical or inhaled corticosteroids.
9. Subjects with significant disease(s) or disorder(s) other than seasonal allergic rhinitis that in the opinion of the investigator may
(i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or
(iii) cause concern regarding subject’s ability to participate in the study.
10. Subjects with history of substance abuse
11. Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive serum pregnancy test at screening.
12. Subjects who are unable or unwilling to comply with the study procedures.
13. Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
14. Subjects who are likely to travel outside the study area for a substantial portion of the study period.
15. Subjects with self-reported chronic diseases like diabetes, kidney diseases, cardiovascular disease
16. Subjects on treatment with any kind of CNS disease (self-reported).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean change in T4NSS, T2OSS and cough scores at each visit as well as from baseline to EOT.
2.Percent change in T4NSS, T2OSS and cough scores at each visit as well as from baseline to EOT.
3.Mean difference in TH1, TH2 TH17 and Treg cells from baseline to EOT
4.Changes in Markers of FOXP3, IL4, IL10, IL17, IL22, IFN-γ, TNF-β, and TNF-α from baseline to EOT
5.Responder rate for T4NSS, T2OSS and cough score
6.Time to response for T4NSS, T2OSS and cough score
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiration rate) at each visit.
2. Change in following parameters at visit 1, 3 and 5
3. Rate of incidence of AE and SAE’s during the Study duration. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/09/2020 |
| Date of Study Completion (India) |
14/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The effect of Bacillus clausii, Bacillus coagulans, Bacillus subtilis and ImmunoSEB is well established for immunomodulatory activity in human studies and also proven to be safe. In this proposed study, immunomodulatory activity of Bacillus clausii 088AE; Bacillus clausii 088AE with Bacillus coagulans LBSC and Bacillus subtilis PLSSC; and ImmunoSEB shall be studied on allergic subjects. Allergy is a common pathophysiology and known for imbalance in various immunity related markers. The present study shall highlight on the efficacy and safety of Bacillus clausii 088AE, ImmunoSEB and a combination of Bacillus clausii 088AE, Bacillus coagulans LBSC and Bacillus subtilis PLSSC to demonstrate immunomodulatory effect in acute allergic rhinitis |