Efficacy of Bacillus Clausii in Acute Diarrhoea in Children

Phase 4

Not yet recruiting

Conditions: Other specified diseases of the digestive system,

Registration Number: CTRI/2021/06/033918

Lead Sponsor: Tablets India Limited

Brief Summary: Acute gastroenteritis is an infectious syndrome that representsthe first cause of hospitalization in children1.Diarrhea is usuallya symptom of an infection in the intestinal tract, which can be caused by avariety of bacterial, viral and parasitic organisms. Infection is spreadthrough contaminated food or drinking water, or from person-to-person as aresult of poor hygiene2. Diarrhea due to infection is widespread throughoutdeveloping countries. In developing countries, children under 5 years of ageexperience on average three episodes of diarrhea every year3.One outof every five children who die of diarrhea worldwide is an Indian. Repeatedepisodes of diarrhea in children can result in long-term deleterious effects onnutritional status, possibly due to intestinal damage. Each episode deprivesthe child from the basic nutrition necessary for growth. As a result, diarrheais a major cause ofmalnutrition, and malnourished children are more likely tofall ill from diarrhea2.Themanagement of acute diarrhoea consists of the replacement of lost fluid withglucose-electrolyte oral rehydration solution. This solution, however, reducesneither the severity nor the duration of diarrhoea4 but hassubstantial benefit in preventing major morbidities due to dehydration and evenmortality. The need of the hour is such agents which reduces both severity andduration of diarrhoea without any major impact on the motility retardation.

Probiotics are live microbial feed supplements that beneficiallyaffect the host by improving its microbial balance. They are commonly used inthe treatment and prevention of acute diarrhea. The rationale for usingprobiotics in acute infectious diarrhea is based on the assumption that theyact against intestinal pathogens5 through a variety of physiologicaland mechanical hostility to pathogens.

Out of many probiotics available, *Bacillus Clausii* is found to be beneficial in reducing prevalence,duration and severity of diarrhea6. This study is aimed to evaluateefficacy of *Bacillus Clausii* intreatment of acute diarrhea in children.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Children aged between 6 months and 10 years with acute bacterial gastroenteritis or acute viral gastroenteritis.
Acute diarrhea for a duration of <3 days.

Exclusion Criteria

Severe dehydration and electrolyte imbalance Presence of systemic infections Children with known immunocomprising morbidities Children with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.No. of stools per day after 24 hours of treatment	1.No. of stools per day after 24 hours of treatment \| 2.No. of stools per day after 48 hours of treatment \| 3.Duration of diarrhoea in days
2.No. of stools per day after 48 hours of treatment	1.No. of stools per day after 24 hours of treatment \| 2.No. of stools per day after 48 hours of treatment \| 3.Duration of diarrhoea in days
3.Duration of diarrhoea in days	1.No. of stools per day after 24 hours of treatment \| 2.No. of stools per day after 48 hours of treatment \| 3.Duration of diarrhoea in days

Secondary Outcome Measures

Name	Time	Method
1.No. of episodes of vomiting	2.Changes in Stool consistency from 24 hrs to 48 hrs.

Trial Locations

Locations (1): Panimalar Medical College Hospital and Research Institute
🇮🇳
Chennai, TAMIL NADU, India
Panimalar Medical College Hospital and Research Institute
🇮🇳Chennai, TAMIL NADU, India
Ramanath A
Principal investigator
9884750160
chandra.ramanath82@gmail.com