| CTRI Number |
CTRI/2018/06/014439 [Registered on: 06/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of Probiotics Bacillus subtilis HU58 and Bacillus coagulans SC209 on Diarrhoea due to antibiotics |
|
Scientific Title of Study
|
An Open Labeled, Placebo Controlled Trial to Evaluate Role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 on Antibiotic associated Diarrhoea in Humans |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VBP – Probiotics-04 /18, Version 1, 10th May 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milind Devale |
| Designation |
Consulting Physician |
| Affiliation |
Kokan Hospital |
| Address |
Kokan Hospital,Areshwar Building, Mhada Colony, Shivneri Vasahat Rd, Kokan Nagar, Jogeshwari East.
Mumbai
MAHARASHTRA
400060
India |
| Phone |
|
| Fax |
|
| Email |
milinddevale75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Dound |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt Ltd |
| Address |
6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
02224055607 |
| Fax |
|
| Email |
yogesh_dound@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Jadhav |
| Designation |
Medical Associate |
| Affiliation |
Synergia Life Sciences Pvt Ltd |
| Address |
6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
02224055608 |
| Fax |
|
| Email |
shashankviridis@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd |
| Address |
6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Milind Devale |
Kokan Hospital |
Medicine Department, Areshwar Building, Mhada Colony, Shivneri Vasahat Rd, Kokan Nagar, Jogeshwari East.
Mumbai
MAHARASHTRA |
022-28374646
milinddevale75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Navsanjeevani Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, Patients having taken antibiotics within four weeks prior to enrollment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical Placebo Capsules |
Each capsule to be given once a day orally after food for 7 days |
| Intervention |
Probiotic Bacillus coagulans SC208 Capsules |
Each capsule to be given once a day orally after food for 7 days |
| Intervention |
Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC208 Capsules |
Each capsule to be given once a day orally after food for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female aged 18 to 65.
2.Stable ECG.
3.Willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1.Sero positive patients.
2.Pregnancy.
3.Subjects who are on other Probiotics or prebiotics.
4.Subjects who are addicted to tobacco, alcohol.
5.Subjects who are on any other medication than prescribed oral antibiotics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of Probiotic- Bacillus subtilis HU58 and Bacillus coagulans SC208 in Antibiotic associated Diarrhoea in Humans in comparison to placebo |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability; clinical variables |
15 days |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/06/2018 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Mehta DS, de Souza A, Jadhav SS and Devale M. An Open Labeled, Placebo Controlled Trial to Evaluate the Role of Probiotics- Bacillus subtilis HU58 and Bacillus Coagulans SC208 0n Antibiotic Associated Diarrhoea In Humans. Biomed J Sci & Tech Res 29(4)-2020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is formulated in order to evaluate the effect of supplementation of Probiotic Bacillus subtilis HU58 and Bacillus coagulans SC209 on Antibiotic associated Diarrhea in humans in comparison with placebo. N = 75 |