| CTRI Number |
CTRI/2024/02/062669 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Bacillus clausii in the management of acute diarrhoea in children |
|
Scientific Title of Study
|
Comparative study on clinical efficacy of Bacillus Clausii ( Bifilac Clausi ) in the management of acute diarrhoea in children as an add on therapy with standard therapy- A randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Karthika |
| Designation |
Second year PG, MD Pharmacology, |
| Affiliation |
Government Kilpauk Medical College |
| Address |
Department of Pharmacology,
Faculty Block 2nd Floor
Government Kilpauk Medical College and Hospital
Chennai
Chennai TAMIL NADU 600010 India |
| Phone |
9655516516 |
| Fax |
|
| Email |
drkkarthika439@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Karthika |
| Designation |
Second year PG, MD Pharmacology, |
| Affiliation |
Government Kilpauk Medical College |
| Address |
Department of Pharmacology
Faculty block 2nd floor
Government Kilpauk Medical College and Hospital
Chennai
Chennai TAMIL NADU 600010 India |
| Phone |
9655516516 |
| Fax |
|
| Email |
drkkarthika439@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aruna |
| Designation |
Professor & Head |
| Affiliation |
Government Kilpauk Medical College and Hospital |
| Address |
Department of Pharmacology
Faculty Block 2nd floor
Government Kilpauk Medical College and Hospital
Chennai
Chennai TAMIL NADU 600010 India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
|
Source of Monetary or Material Support
|
| STUDY SAMPLES TO BE PROVIDED BY TABLETS INDIA LIMITED to Government Kilpauk Medical College, Chennai |
|
|
Primary Sponsor
|
| Name |
Tablets India Limited |
| Address |
No 72 Marshalls Road
Egmore
Chennai - 600008 |
| 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 Karthika |
Government Kilpauk Medical College |
Department of Paediatrics,
Ground floor
822 Poonamallee High Rd
Kilpauk Chennai
Tamil Nadu 600010 Chennai TAMIL NADU |
9655516516
drkkarthika439@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GovernmentKilpaukMedicalCollegeInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A084||Viral intestinal infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bifilac Clausi + ORS + Zinc |
Bacillus clausii 2 billion CFU for 5 days BD
ORS
Zinc sulphate 20 mg for 14 days |
| Comparator Agent |
ORS + Zinc |
ORS + Oral Zinc sulphate |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 6 months to 5 years old with care of diarrhoea less than 3 days |
|
| ExclusionCriteria |
| Details |
Children with severe dehydration
Presence of systemic infections
Children with known immunocompromising morbidities
Children with severe acute malnutrition, Children with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of loose stools |
24 hours and 72 hours and 120 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in stool consistency |
24 hours & 72 hours & 120 hours |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
26/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/02/2024 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Open access
- For how long will this data be available start date provided 01-03-2024 and end date provided 29-05-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Acute diarrhoea is defined as a change in the consistency of stool leading to loose or liquid stools and/or an increase in the frequency of evacuations to three or more in 24 hours with or without fever or vomiting lasting 7 days or less. Diarrhoea is usually a symptom of an infection in the intestinal tract, which can be caused by a variety of bacterial, viral and parasitic organisms. It is the most common cause of mortality among under five children in developing countries. Infection is spread through contaminated food or drinking water or from person-to-person as a result of poor hygiene. Diarrhoea due to infection is widespread throughout developing countries. In developing countries, children under 5 years of age experience on average three episodes of diarrhoea every year. Repeated episodes of diarrhoea in children can result in long-term deleterious effects on nutritional status, possibly due to intestinal damage. Each episode deprives the child from the basic nutrition necessary for growth. The management of acute diarrhoea consists of the replacement of lost fluid and electrolytes with oral rehydration to reduce the complications like dehydration, electrolyte disturbances and metabolic acidosis. Probiotics are live microbial feed supplements that beneficially affect the host by improving the microbial balance. They are commonly used in the treatment and prevention of acute diarrhoea. Out of many probiotics available, Bacillus clausii is found to be beneficial in reducing intensity and duration of diarrhea in children aged 6 months to 5 years. |