| CTRI Number |
CTRI/2025/03/083029 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of novel synbiotic (ByRx) in addressing dysbiosis in Paediatric patients prescribed with anti-biotics |
|
Scientific Title of Study
|
A prospective, open label, randomized, comparative, proof of science, clinical safety and efficacy study of novel Synbiotic (ByRx) in children having antibiotic associated dysbiosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240063-IN, Version 1.0 05 Mar 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari N Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmadabad
Ahmadabad
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Inzpera Health science Limited
a subsidiary of Tata industries Limited
215-217, Avior Corporate Park,
Nirmal Galaxy, LBS Marg,
Mulund West, Mumbai-400080
|
|
|
Primary Sponsor
|
| Name |
Inzpera health Science Limited |
| Address |
Inzpera Health science Limited a subsidiary of Tata industries Limited 215-217, Avior Corporate Park, Nirmal Galaxy, LBS Marg, Mulund West, Mumbai-400080 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Private Limited |
Clinical Trial Department, Office 313, Silver Radiance-4, 3rd Floor, Gota,
Ahmedabad, Gujarat, India - 382481
Ahmadabad
GUJARAT |
9909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antibiotic |
Mode of Usage: Take the required dose of antibiotic as directed by paediatrician
Frequency: As directed by paediatrician
Duration of study: 14 Days
Route of Administration: Oral
|
| Intervention |
Test product A: ByRx powder |
Mode of Usage: Oral (Dissolved in 25ml water)
Frequency: Once a day on empty stomach.
Duration of study: 14 Days
Route of Administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 02 to 12 years (both inclusive) at the time of consent.
2) Sex: male and females.
3) Subjects having symptoms of URTI or gastro infection (dysbiosis) which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
4) Willing to give written parental informed consent and are willing to come for regular follow-up on the study site.
5) Who commit not to use other probiotics, synbiotic, prebiotics, and anti-biotic for their child other than the test product for the entire duration of the study.
6) Subject who has not participated in a similar investigation in the past three months.
7) Willing to use test product throughout the study period
8) subject having refrigerator at home
|
|
| ExclusionCriteria |
| Details |
1.Subjects with suspected or confirmed organic causes of constipation (e.g., Hirschsprung’s disease, hypothyroidism, structural anal anomalies).
2.Subjects with an allergic response to any prebiotic, probiotic, or synbiotic product.
3.Subjects on chronic medication (e.g., aspirin, anti-inflammatories, antihistamines, corticosteroids) that may affect study outcomes.
4.Subjects with major diseases in cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or endocrine systems.
5.History of alcohol or drug addiction.
6.Subjects with a history of major gastrointestinal complications (e.g., Crohn’s disease, ulcers, cancer, ulcerative colitis).
7.Subjects participating in similar trials within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product in terms of change in
1. diversity and richness of gut microbiome
2.faecal output ratio
3.stool based on the Bristol Stool Criteria
4. abbreviated physical examinations
5. ROME III criteria |
On day Day 01, after product administration Day 06 and on day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effectiveness of the test product in terms of subject perception questionnaire from baseline before and after usage of the test product.
2.To assess the effectiveness of the test product in terms of occurrence of the adverse event after usage of the test product.
|
On day Day 01, after product administration Day 06 and on day 14 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
28/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a prospective, open-label, randomized, comparative, proof-of-concept study evaluating the clinical safety and efficacy of a novel synbiotic treatment in children with antibiotic-associated dysbiosis. The study will be conducted in two cohorts: · Cohort 1: A total of 12 patients (6 per arm) will participate. Six patients will receive antibiotics alone, while the other six will receive antibiotics combined with the synbiotic for 5 days. For the synbiotic arm, Days 6 and 7 will involve synbiotic administration only. · Cohort 2: If the results from Cohort 1 are satisfactory, an additional up to 32 (16 subjects per arm) will be enrolled. The subjects will be instructed to visit the facility as per the below visits. Visit 01 (Day 01): Screening, ICD, Enrolment, Stool Sample Collection, Antibiotic treatment 5 Days antibiotic period Visit 02 (Day 06): Stool Sample Collection, test treatment period Visit 03 (Day 11 to Day 14 ): Test Treatment stop, Stool Sample Collection, End of The Study |