| CTRI Number |
CTRI/2024/01/061370 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Other |
|
Public Title of Study
|
Role of Probiotics in acute diarrhea in children of age 6 months to 5 years. |
|
Scientific Title of Study
|
Safety and Efficacy of saccharomyces boulardii (CNCM I-745) in acute diarrhea in children of age 6 months to 5 years.A Randomized Double blind controlled study. |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumari Akanksha Rani |
| Designation |
PG Resident |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
I block
Pediatric OPD
1st floor
Udaipur
RAJASTHAN
313002
India |
| Phone |
8001715381 |
| Fax |
|
| Email |
aks08kar1712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY MANDOT |
| Designation |
PROFESSOR AND UNIT HEAD |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
I3 BLOCK PEDIATRIC OPD
1ST FLOOR
GEETANJALI MEDICAL COLLEGE AND HOSPITAL
UDAIPUR
RAJASTHAN
Udaipur
RAJASTHAN
313002
India |
| Phone |
9462022900 |
| Fax |
|
| Email |
drmandot@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJAY MANDOT |
| Designation |
PROFESSOR AND UNIT HEAD |
| Affiliation |
Geetanjali Medical College and Hospital |
| Address |
I3 BLOCK PEDIATRIC OPD
1ST FLOOR
GEETANJALI MEDICAL COLLEGE AND HOSPITAL
UDAIPUR
Udaipur
RAJASTHAN
313002
India |
| Phone |
9462022900 |
| Fax |
|
| Email |
drmandot@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Geetanjali Medical College and Hospital
Manvakheda
Udaipur
Rajasthan |
|
|
Primary Sponsor
|
| Name |
Kumari Akanksha Rani |
| Address |
Room no 555
Old PG hostel
GMCH,Udaipur |
| Type of Sponsor |
Other [PG RESIDENT] |
|
|
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 |
| Kumari Akanksha Rani |
Geetanjali Medical College and Hospital |
Room I-2
Pediatric OPD
1st floor
Geetanjali Hospital
Udaipur
RAJASTHAN |
8001715381
aks08kar1712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Saccharomyces boulardii (CNCM I-745) treated group |
The amount,consistency and frequency of stool will analyzed for efficacy and adverse effects will be noted for safety those treated with Saccharomyces boulardii sachet . |
| Comparator Agent |
Standard medical treatment (SMT) group |
The amount, consistency and frequency of stool will analyzed those treated with standard medical treatment(SMT). |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All the children age between 6 months to 5 years attending out patient department of Pediatrics with diagnosis of acute diarrhea. |
|
| ExclusionCriteria |
| Details |
History of presence of blood in stool,Clinical signs of severe malnutrition,Clinical signs of severe dehydration,Treatment with antibiotics/probiotics,Coexisting acute systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To evaluate safety and efficacy of saccharomyces boulardii in acute diarrhea in children of age 6 months to 5 years. |
On day 3 and day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse other associated clinical features in acute diarrhea. |
on day 3 and day 6 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
18/01/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is Randomized Controlled Trial to evaluate safety and efficacy of Saccharomyces Boulardii (CNCM I-745) in acute diarrhea in children of age 6 months to 5 years.Study will be conducted at Geetanjali hospital ,UDAIPUR. |