GI Tolerance Clinical Trial
Official title:
A Prospective, Open-label, Post-marketing Observational Study to Evaluate the Effects of High-fiber Enteral Pediatric Formula in Children With Failure to Thrive Due to Malnutrition
| Verified date | June 2016 |
| Source | Abbott Nutrition |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey: Ministry of Health |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 345 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 10 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Ankara Üniversitesi Tip Fakültesi | Ankara | |
| Turkey | Trakya Üniversitesi Tip Fakültesi | Edirne | |
| Turkey | Firat Üniversitesi Tip Fakültesi | Elazig | |
| Turkey | Özel Dogu Anadolu Hastanesi | Elazig | |
| Turkey | Gaziantep Üniversitesi Tip Fakültesi | Gaziantep | |
| Turkey | Dr.Sadi Konuk Egitim ve Arastirma Hastan | Istanbul | |
| Turkey | Medeniyet Üniversitesi Göztepe Egitim ve Arastirma Hastanesi | Istanbul | |
| Turkey | Memorial Sisli Hastanesi | Istanbul | |
| Turkey | Behçet Uz Çocuk Hastaliklari Hastanesi | Izmir | |
| Turkey | Izmir Tepecik Egitim ve Arastirma Hastanes | Izmir | |
| Turkey | Sifa Üniversitesi Bornova Saglik Uygulama ve Arastirma Merkezi | Izmir | |
| Turkey | Erciyes Üniversitesi Tip Fakültesi | Kayseri? | |
| Turkey | Kirikkale Üniversitesi Tip Fakültesi | Kirikkale | |
| Turkey | Kocaeli Üniversitesi Tip Fakültesi | Kocaeli | |
| Turkey | Konya Üniversitesi Selçuk Tip Fakültesi | Konya | |
| Turkey | Ondokuz Mayis Üniversitesi Tip Fakültesi | Samsun | |
| Turkey | Samsun Kadin Dogum ve Çocuk Hastanesi | Samsun |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Nutrition |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Physician Perception of Formula Use | Questionnaire | Baseline to Month 6 | No |
| Secondary | Gastrointestinal Tolerance | Subject questionnaires | Baseline to Month 1, Month 2, Month 4 and Month 6 | No |
| Secondary | Description of Population | Demographic collection of patients recommended high-fiber enteral formula | Baseline | No |
| Secondary | Weight | Baseline to Month 1, Month 2, Month 4 and Month 6 | No |