| CTRI Number |
CTRI/2024/01/061546 [Registered on: 17/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Probiotics in Treating Acute Gastroenteritis. |
|
Scientific Title of Study
|
A cross-sectional study to assess the real world
utilization and safety of
Multistrain probiotic in Acute gastroenteritis in outpatient settings of India (MAESTRO Study) |
| Trial Acronym |
MAESTRO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavna Patel |
| Designation |
Principal Investigator |
| Affiliation |
Medicure Hospital |
| Address |
Department of Medicine, Medicure Hospital, 3rd floor, SR Square, Nikol
Ahmadabad
GUJARAT
382350
India |
| Phone |
9712928980 |
| Fax |
|
| Email |
drbhavnapatel82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnaprasad K MD |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road
Terapanth Road Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathish Nair PhD MBA |
| Designation |
Assistant General Manager - Medical Strategic Affairs |
| Affiliation |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road
Terapanth Road Navrangpura
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000560 |
| Fax |
|
| Email |
RathishNair@TorrentPharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd 968 Torrent House Off Ashram Road Terapanth Road Navrangpura
Ahmedabad Gujarat 380009 |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
968 Torrent House Off Ashram Road Terapanth Road Navrangpura
Ahmedabad Gujarat 380009 |
| 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 Bhavna Patel |
Medicure Hospital |
Department of Medicine, Medicure Hospital, 3rd floor, SR Square, Nikol
Ahmadabad
GUJARAT |
9712928980
drbhavnapatel82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K529||Noninfective gastroenteritis and colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute gastroenteritis and treated with multistrain probiotics for 7 days |
|
| ExclusionCriteria |
| Details |
Contraindications to ingredients.
Any other condition or factors as per discretion of treating physician. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in stool frequency and consistency after probiotic administration. |
From baseline (Day-0) to Day-7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Most common cause of acute gastroenteritis.
Change in ORS requirement.
Safety assessment.
Dosage frequency for probiotics.
Concomitant medications. |
From baseline (Day-0) to Day-7 |
|
|
Target Sample Size
|
Total Sample Size="3905"
Sample Size from India="3905"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
- Aim of this study is to assess the real world utilization and safety of multistrain probiotic in acute gastroenteritis in outpatient settings of India.
- Study design: A Real World, Cross-sectional Study
- Duration of study: 6 months
- Duration of observation: 1 week
Srteptococcus faecalis 30 million
Clostridium butyricum 2 million
Bacillus mesentricus 1 million
Lactobacillus Sporogenes 50 million
Saccharomyces boulardii 50 million - Dosage Form Oral solid
- Dosage As directed by the physician
- Route of Administration: Oral
As the study will be conducted in the real life setting, study medication will be prescribed by the investigator and the patients will purchase the drug from the pharmacy. Compliance will be assessed from the case record sheets. Source data will be assessed for compliance and captured appropriately and regularly monitored by the sponsor for classification as treatment completers. |