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

NCT ID: NCT02819401

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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GI Tolerance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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pediatric formula

high-fiber enteral formula

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aysugul Alptekin, MD

Role: STUDY_CHAIR

Abbott Turkey

Locations

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Ankara Üniversitesi Tıp Fakültesi

Ankara, , Turkey (Türkiye)

Site Status

Trakya Üniversitesi Tıp Fakültesi

Edirne, , Turkey (Türkiye)

Site Status

Fırat Üniversitesi Tıp Fakültesi

Elâzığ, , Turkey (Türkiye)

Site Status

Özel Doğu Anadolu Hastanesi

Elâzığ, , Turkey (Türkiye)

Site Status

Gaziantep Üniversitesi Tıp Fakültesi

Gaziantep, , Turkey (Türkiye)

Site Status

Memorial Şişli Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Dr.Sadi Konuk Eğitim ve Araştırma Hastan

Istanbul, , Turkey (Türkiye)

Site Status

Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi

Izmir, , Turkey (Türkiye)

Site Status

Behçet Uz Çocuk Hastalıkları Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

İzmir Tepecik Eğitim ve Araştırma Hastanes

Izmir, , Turkey (Türkiye)

Site Status

Erciyes Üniversitesi Tıp Fakültesi

Kayseri̇, , Turkey (Türkiye)

Site Status

Kocaeli Üniversitesi Tıp Fakültesi

Kocaeli, , Turkey (Türkiye)

Site Status

Konya Üniversitesi Selçuk Tıp Fakültesi

Konya, , Turkey (Türkiye)

Site Status

Kırıkkale Üniversitesi Tıp Fakültesi

Kırıkkale, , Turkey (Türkiye)

Site Status

Samsun Kadın Doğum ve Çocuk Hastanesi

Samsun, , Turkey (Türkiye)

Site Status

Ondokuz Mayıs Üniversitesi Tıp Fakültesi

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ANTK1001

Identifier Type: -

Identifier Source: org_study_id