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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Open access

  6. 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.

  7. 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.

 
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