Comparison of a lactose-free medical diet and a lactose-free formula in acute childhood diarrhea
- Conditions
- acute diarrhea in children.diarrhea, lactose-free medical formula, children
- Registration Number
- TCTR20240706013
- Lead Sponsor
- Thai Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
1.Patients of both sexes who are at 6-24 months
2.Taking non lactose-free formula milk
3. Admitted at the hospital with watery diarrhea at least 1 time or diarrhea more than 3 times within 1 day but not more than 7 day
4.Obtain inform consent form his/her legal representative
1. Taking lactose-free formula within 7 days previous enrollment.
2. Sepsis
3. Severe dehydration
4. Having history or diagnosed with Inflammatory bowel disease, necrotizing enterocolitis, intussusception, volvulus, celiac disease, immune deficiency, chronic disease that effect study outcome, advance cancer and terminal disease
6. Taking only breast milk
7. Not able to taking investigated product.
8. Taking prebiotic within 7 days previous enrollment.
9. Taking antibiotic within 7 days previous enrollment.
10. Taking smecta, hidrasec or dehecta within 7 days previous enrollment.
11. Having mucus bloody diarrhea
12. Allergic to cow's milk or components of study formula .
13. Taking other investigated product or stop taking not more than 30 days previous enrollment.
14. Having bacterial infection (except GI system) and taking antibiotic
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diarrheal symptoms (stool characteristics and frequency) Enrollment, discharge the hospital and follow up visit Observation
- Secondary Outcome Measures
Name Time Method Body weight Enrollment, discharge the hospital and follow up visit Weighing,Gastrointestinal adverse event During the study Observation,quality of life of subject and their parent End of the study Questioniare,Cost of lactose-free formula in the study End of the study Calculation