Assessment of the Efficacy of Probiotics in reducing the Duration and Severity of Acute Diarrhea in Children under 5 years of age in a Tertiary care hospital of Uttar Pradesh

1)INTRODUCTION:

Acute diarrhea remains the leading cause of morbidity and mortality among children under five years of age, particularly in low and middle income countries. In India, the burden is substantial, with acute diarrhea contributing significantly to under 5 mortality rates.

2)CURRENT GAPS IN KNOWLEDGE:

A major gap in knowledge is the variability in strain selection probiotic, dose, duration, how it affects severity and duration of acute diarrhea. . Another gap is the limited exploration of how nutritional status, breastfeeding, or antibiotic exposure modulates probiotic efficacy. In real Indian settings, compliance, affordability, and availability of specific strains could influence outcomes. thus context specific research is necessory to validate probiotic use in acute diarrhea in India.

3)AIM AND OBJECTIVES:

Aim:

To evaluate whether the addition of probiotics to standard therapy (ORS and Zinc) reduces the duration and severity of acute diarrhea in children under 5 years of age, thereby contributing to improved clinical outcomes and reduced healthcare burden .

Primary Objective:

To assess the effectiveness of probiotics in reducing the duration (in hours) of acute diarrhea in children aged 6 months to 59 months.

Secondary Objectives:

To compare the severity of diarrhea using the modified vesikari score between probiotic and control groups.

To evaluate the frequency of stool output and time to clinical recovery in both groups

To assess the need for hospitalization and duration of hospital stay in both groups.

4)HYPOTHESIS:

Null hypothesis:

There is no significant difference in the duration and severity of acute diarrhea between children under 5 years receiving probiotics along with standard therapy and those receiving standard therapy alone.

5)MATERIAL AND METHODS:

 

Study design:

This will be a prospective, single blinded, randomized control study.

 

Recruitment method:

Eligible patients will be screened by peadiatric residents, those meeting inclusion criteria will be recruited after informed consent.

6. INCLUSION AND EXCLUSION CRITERIA  :

Inclusion criteria:

Children aged 6 months to 59 months.

Onset of acute diarrhea within the last 48 hours( defined as 3 or more watery stools per day).

Exclusion criteria:

Chronic diarrhea (lasting more than 14 days)

Severe acute malnutrition

Known immunodeficiency syndromes

Severe comorbid conditions

Recent antibiotic use in last 7 days

Dysentry

Known hypersensitivity to probiotics

7. TYPE OF INTERVENTION :

GROUP A (PROBIOTIC GROUP):

Intervention : Bacillus clausii suspension (2 billion spores/ day)

Route : Oral

Duration: 5 days of probiotic or earlier if resolved.

Along with: Standard therapy (ORS plus Zinc)

GROUP B (PLACEBO GROUP):

Intervention : Placebo suspension (Distilled water or normal saline) identical in appearance of probiotics formulations.

Along with: Standard therapy (ORS plus Zinc).

Route : Oral.

8)ETHICAL APPROVAL AND REGULATORY APPROVAL:

The protocol is approved by Institutional Ethics Committee of Noida International Institute of Medical Sciences.

9. FOLLOW UP :

Participants will be followed daily either in person ( if admitted) or via phone(if managed at home.

A structured case report form (CRF) will be used to record daily symptoms, stool frequency, and adverse events.