| CTRI Number |
CTRI/2021/10/037398 [Registered on: 20/10/2021] Trial Registered Prospectively |
| Last Modified On: |
02/05/2022 |
| 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 see effect of Bacillus subtilis HU58 and Bacillus coagulans SC208 syrup in treatment of acute diarrhoea in children |
|
Scientific Title of Study
|
A Multicentre, Randomized, Double Blind, Parallel Group, Placebo Controlled Clinical Trial to Evaluate Efficacy and Safety of Bacillus subtilis HU58 + Bacillus coagulans SC208 Syrup in Treatment of Acute Diarrhoea in Children. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BCR-SYN-001 Version 2.0 Dated 28 Sep 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Ramchandra Dhongade |
| Designation |
Principal Investigator |
| Affiliation |
Sant Dnyaneshwar Medical Education and Research Centre |
| Address |
695-A Sadashiv peth, Laxmi Road, Opp. Vijay Talkies, Pune-
411030, Maharashtra.
Pune
MAHARASHTRA
411030
India |
| Phone |
9011095436 |
| Fax |
|
| Email |
adhongade1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction, Thane west
Thane
MAHARASHTRA
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank S Jadhav |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt. Ltd |
| Address |
Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai, Maharashtra 400071, India
Mumbai
MAHARASHTRA
400071
India |
| Phone |
02262669600 |
| Fax |
|
| Email |
shashank@viridisbiopharma.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences, Pvt. Ltd., Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai, Maharashtra 400071, India. |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd |
| Address |
Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai, Maharashtra 400071, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suhas Kulkarni |
Chiranjeevi Hospital |
1st floor,
Anand Chambers, Opposite TMC Building,
Almeda Road, Ganeshwadi, Thane-400606,
Maharashtra, India.
Thane
MAHARASHTRA |
9820039614
fromsuhas@yahoo.com |
| Dr Sanjay Sudhakar Joshi |
JMFS ACPM Medical College and Hospital |
Department of Paediatrics, JMFS ACPM Medical College and Hospital,Sakri Road, Dhule,
Maharashtra
Dhule
MAHARASHTRA |
9545451067
asj1001ssj@gmail.com |
| Dr Ashish Ramchandra Dhongade |
Sant Dnyaneshwar Medical Education and Research Centre |
Dept. of Paediatrics,
ground floor, 69FA Sadashiv peth, Laxmi Road, Opp. Vijay Talkies, Pune-411030, Maharashtra
Pune
MAHARASHTRA |
9011095436
adhongade1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee JMFS ACPM Medical College, Dhule |
Approved |
| Sant Dnyaneshwar Medical Education and Research Centre Institutional Review Board |
Approved |
| V Care Independent Ethics Committee, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Identical Placebo Syrup |
5 ml of syrup to be given once a day orally for 7 days.
The dose will be increased to twice daily at visit 3 (Day 3) as per Investigators discretion based on the clinical condition of the subject in both the cohorts. |
| Intervention |
Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC208 Syrup |
5 ml of syrup to be given once
a day orally for 7 days
The dose will be increased to twice daily at visit 3 (Day 3) as per Investigators discretion based on the clinical condition of the subject in both the cohorts. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female subjects between ≥1 to ≤ 12years of age both inclusive.
2. The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child will comply with the requirements of the protocol.
3. Written informed consent /assent obtained from the parent(s)/LAR(s) of the subject and the subject respectively for participation in the study.
Cohort 1:
1. Subjects undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.
2. Subject suffering from Antibiotic-associated Diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period.
Cohort 2:
1. Subject with clinical diagnosis of acute infective diarrhoea defined as passage of three or more liquid or watery stools occurring in a 24-hour period and lasting for less than three days). |
|
| ExclusionCriteria |
| Details |
1. History of pre-existing diarrhoea within the previous 4 weeks.
2. Subjects requiring hospitalisation.
3. Subjects with Severe dehydrationrequiring intravenous rehydration.
4. Subjects with bloody and/or purulent stools
5. Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn‘s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhoea and functional constipation.
6. Subjects with gastrointestinal surgery.
7. History of severe chronic systemic diseases, critical/life-threatening illness or immunodeficiency diseases.
8. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo.
9. Use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic 14 days before and during the study
10. Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study.
11. Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Stool consistency (as assessed by Bristol Stool Scale (BSS)[ including 7 types as follows: type 1 to 2 indicates constipation; type 3 to 5 suggests normal stools; and type 6 to 7 means liquid stool]
2.Duration of diarrhoea in days (time between the start of treatment until last diarrheal/watery stool before recovery or end of study treatment). |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Abdominal pain intensity [as measured by visual analogue scale (VAS)]. |
7 Days |
| The assessment of safety of Investigational Product will be based on the frequency of Adverse Events and changes in laboratory values. All safety variables will be summarized using descriptive statistics |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/10/2021 |
| Date of Study Completion (India) |
07/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The overall study will be conducted in subjects with acute diarrhoea. A (-1) day screening period and a treatment period of 7 Days. The duration of individual participation will be approximately 7 days. Eligible patients will be randomized in two arms.The subjects would be assigned to Arm A(test group) or Arm B(placebo) in the ratio of 1:1 (16:16 subjects per Arm) for both the cohorts. For both the cohorts subjects will be assessed for the safety and efficacy from baseline to the end of study visit
The primary outcome evaluates Stool consistency as assessed by Bristol Stool Scale (BSS) and duration of diarrhoea in days. A secondary outcome evaluates abdominal pain intensity as assessed by the visual analogue scale from baseline to end of study. Safety will be assessed on the frequency of Adverse Events and changes in laboratory values. |