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OpenTrials
Completed

NCT Number: NCT02819401

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

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.

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Key information

Conditions

GI Tolerance

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Üniversitesi Tıp Fakültesi, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Formula

Other

high-fiber enteral formula

Primary outcomes

  1. Physician Perception of Formula Use

    Time frame: Baseline to Month 6

    Questionnaire

Secondary outcomes

  1. Gastrointestinal Tolerance

    Time frame: Baseline to Month 1, Month 2, Month 4 and Month 6

    Subject questionnaires

  2. Description of Population

    Time frame: Baseline

    Demographic collection of patients recommended high-fiber enteral formula

  3. Weight

    Time frame: Baseline to Month 1, Month 2, Month 4 and Month 6

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2016
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.