The Effects of a High-fiber Formula in Children With Failure to Thrive

Completed

• Conditions: GI Tolerance

• Registration Number: NCT02819401
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-03-18
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physician Perception of Formula Use	Baseline to Month 6	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Weight	Baseline to Month 1, Month 2, Month 4 and Month 6
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

Trial Locations

Locations (17)

Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey

Dr.Sadi Konuk Eğitim ve Araştırma Hastan; 🇹🇷 Istanbul, Turkey

Trakya Üniversitesi Tıp Fakültesi; 🇹🇷 Edirne, Turkey

Gaziantep Üniversitesi Tıp Fakültesi; 🇹🇷 Gaziantep, Turkey

Behçet Uz Çocuk Hastalıkları Hastanesi; 🇹🇷 İzmir, Turkey

Erciyes Üniversitesi Tıp Fakültesi; 🇹🇷 Kayseri̇, Turkey

Samsun Kadın Doğum ve Çocuk Hastanesi; 🇹🇷 Samsun, Turkey

Ondokuz Mayıs Üniversitesi Tıp Fakültesi; 🇹🇷 Samsun, Turkey

Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi; 🇹🇷 İzmir, Turkey

Memorial Şişli Hastanesi; 🇹🇷 İstanbul, Turkey

Konya Üniversitesi Selçuk Tıp Fakültesi; 🇹🇷 Konya, Turkey

Ankara Üniversitesi Tıp Fakültesi; 🇹🇷 Ankara, Turkey

Fırat Üniversitesi Tıp Fakültesi; 🇹🇷 Elazığ, Turkey

Özel Doğu Anadolu Hastanesi; 🇹🇷 Elazığ, Turkey

İzmir Tepecik Eğitim ve Araştırma Hastanes; 🇹🇷 İzmir, Turkey

Kocaeli Üniversitesi Tıp Fakültesi; 🇹🇷 Kocaeli, Turkey

Kırıkkale Üniversitesi Tıp Fakültesi; 🇹🇷 Kırıkkale, Turkey