| CTRI Number |
CTRI/2018/01/011186 [Registered on: 08/01/2018] 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 on Diarrhoea due to antibiotics
|
|
Scientific Title of Study
|
An Open Labeled, Placebo Controlled Trial to Evaluate Role of Probiotic- Bacillus subtilis HU58 on Antibiotic associated Diarrhoea In Humans |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VBP – Probiotics-03 /17 |
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 |
022-24055607 |
| 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 |
022-24055608 |
| Fax |
|
| Email |
shashankviridis@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences Pvt Ltd, 6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai 400 022, India. |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd |
| Address |
6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai 400 022, India. |
| 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 |
| Inter System BioMedica Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having taken antibiotics within four weeks prior to enrollment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Capsules |
Each capsule identical to Probiotic Bacillus subtilis HU58 capsule to be given once a day orally after food for 7 days |
| Intervention |
Probiotic Bacillus subtilis HU58 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 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="60"
Sample Size from India="60"
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)
|
22/01/2018 |
| 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. Probiotic Bacillus subtilis HU58 for the Management of Antibiotic Associated Diarrhoea in adults. The Indian Practitioner 2020;(5) |
|
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 Bacillus subtilis HU58 Probiotics on Antibiotic associated Diarrhea in humans in comparison with placebo. N = 60 |