A study to evaluate the beneficial effects of probiotics by supplementing with standard of care in the treatment of diarrhea affecting infants and children with mild to moderate dehydration.
Phase 4
- Conditions
- Health Condition 1: K639- Disease of intestine, unspecified
- Registration Number
- CTRI/2024/01/061278
- Lead Sponsor
- JHAVER Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children of either sex aged 6 months to 5 years suffering from acute diarrhea with moderate dehydration (duration < 3days)
Exclusion Criteria
Children with history of malabsorption syndromes.
Having respiratory infections / systemic infection.
Children with hypersensitivity to any of the components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure of <br/ ><br>Number of episodes (frequency) of diarrhea in a day <br/ ><br>Mean duration of diarrhea (in days) <br/ ><br>Duration and volume of oral rehydration salt [ORS] therapy <br/ ><br>Duration and volume of intravenous fluid [IVF] therapy <br/ ><br>Consistency of stool by Bristol stool scale. <br/ ><br>Timepoint: 5 days study period
- Secondary Outcome Measures
Name Time Method secondary outcome will be assessed by the occurrence of adverse events (if worsening of existing symptoms, hypersensitivity reactions) following the administration of probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow. <br/ ><br>Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the diaryTimepoint: 5 days study period