The Role of Probiotic in the treatment of diarrhea among childre
- Conditions
- Health Condition 1: A09- Infectious gastroenteritis and colitis, unspecified
- Registration Number
- CTRI/2020/04/024633
- Lead Sponsor
- Renata Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 0
i. Children age: from 1 month to 12 years
ii. Patients with both sexes
iii. Patients who will suffer from dehydrating acute watery diarrhea of less than 14 days
iv. Patients with clinical signs and symptoms of â??someâ?? dehydration
(Thirst or eagerness to drink, sunken eyes, dry mouth and tongue and loss of skin elasticity (WHO 2006)
v. Children who will have capacity to take oral medications
i.Patients who will have a history of an episode of diarrhea within one month of the present illness to exclude recurrent and persistent diarrhea
ii.Patients who will have severe dehydration
iii.Patients will have severe malnutrition as defined by Waterlow classification
iv.Patients who will have diarrhea associated with another systemic illness (e.g. septicemia, pneumonia, urinary tract infection, and otitis media
v. Patients who will have known hypersensitivity reaction to probiotics
vi. Patients who will receive any antibiotic therapy within 1 month prior to inclusion in study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters: <br/ ><br>1.Frewuency and consistency of stool <br/ ><br>2. Sign of dehydration <br/ ><br>3. Temperature <br/ ><br>This will be measured depending upon duration of diarrhea after intervention. <br/ ><br>Timepoint: Baseline (Day 0) to complete recovery <br/ ><br>
- Secondary Outcome Measures
Name Time Method a. Stool samples will be processed for the detection of established enteric pathogens including bacteria, viruses, parasites and other gut microbiota using standard techniques. <br/ ><br>Timepoint: Day 0 and day 30;b. Blood samples will be analyzed for the measurement of immunoglobulin level.Timepoint: Day 0 and Day 30