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

June 28, 2016 updated by: Abbott Nutrition

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Üniversitesi Tıp Fakültesi
      • Edirne, Turkey, 22030
        • Trakya Üniversitesi Tıp Fakültesi
      • Elazığ, Turkey, 23200
        • Fırat Üniversitesi Tıp Fakültesi
      • Elazığ, Turkey
        • Özel Doğu Anadolu Hastanesi
      • Gaziantep, Turkey, 27070
        • Gaziantep Üniversitesi Tıp Fakültesi
      • Istanbul, Turkey, 34722
        • Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi
      • Istanbul, Turkey
        • Dr.Sadi Konuk Eğitim ve Araştırma Hastan
      • Kayseri̇, Turkey, 38039
        • Erciyes Üniversitesi Tıp Fakültesi
      • Kocaeli, Turkey
        • Kocaeli Üniversitesi Tıp Fakültesi
      • Konya, Turkey, 42250
        • Konya Üniversitesi Selçuk Tıp Fakültesi
      • Kırıkkale, Turkey
        • Kırıkkale Üniversitesi Tıp Fakültesi
      • Samsun, Turkey, 55139
        • Ondokuz Mayıs Universitesi Tıp Fakültesi
      • Samsun, Turkey, 55070
        • Samsun Kadın Doğum ve Çocuk Hastanesi
      • İstanbul, Turkey, 34385
        • Memorial Şişli Hastanesi
      • İzmir, Turkey, 35100
        • Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi
      • İzmir, Turkey
        • Behçet Uz Çocuk Hastalıkları Hastanesi
      • İzmir, Turkey
        • İzmir Tepecik Eğitim ve Araştırma Hastanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with failure to thrive who are receiving a high-fiber enteral formula for supportive treatment as part of the routine healthcare service in Turkey.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Perception of Formula Use
Time Frame: Baseline to Month 6
Questionnaire
Baseline to Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Tolerance
Time Frame: Baseline to Month 1, Month 2, Month 4 and Month 6
Subject questionnaires
Baseline to Month 1, Month 2, Month 4 and Month 6
Description of Population
Time Frame: Baseline
Demographic collection of patients recommended high-fiber enteral formula
Baseline
Weight
Time Frame: Baseline to Month 1, Month 2, Month 4 and Month 6
Baseline to Month 1, Month 2, Month 4 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Aysugul Alptekin, MD, Abbott Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTK1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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