GI Tolerance
Conditions
Brief summary
The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of the routine healthcare service in Turkey.
Interventions
OTHERpediatric formula
high-fiber enteral formula
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Age; 1-10 years (inclusive) * Children diagnosed as failure-to-thrive(FTT). * Children who have been recently prescribed and treatment initiated with isocaloric or hypercaloric high-fiber pediatric enteral formula suitable for oral and/or nasogastric tube feeding before inclusion in the study.
Exclusion criteria
* Chronic renal disorder * Decompensated liver disease * Any other chronic condition that was not under control (e.g. diabetes, thyroid disorder, etc.) * Any type of malignant disease including leukemia and lymphoma * Cystic fibrosis * Short bowel syndrome * Any type of food allergy or intolerance * Growth hormone deficiency * Use of enteral feeding within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Perception of Formula Use | Baseline to Month 6 | Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Baseline to Month 1, Month 2, Month 4 and Month 6 | Subject questionnaires |
| Description of Population | Baseline | Demographic collection of patients recommended high-fiber enteral formula |
| Weight | Baseline to Month 1, Month 2, Month 4 and Month 6 | — |
Countries
Turkey (Türkiye)
Outcome results
None listed