acute diarrhea in children. diarrhea, lactose-free medical formula, children
Conditions
Interventions
Replace their old milk with investigated product as their usual practice. First phase: Admitted at the hospital not more than 14 day. Follow up phase: not more than 7 days.,Replace their old milk with
Lactose-free medical formula ,Lactose-free formula
Sponsors
Thai Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
6 Months to 24 Months
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrheal symptoms (stool characteristics and frequency) Enrollment, discharge the hospital and follow up visit Observation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactPannatorn Panyapalungkul
Thai Otsuka Pharmaceutical Co., Ltd.
Outcome results
None listed