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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Mal

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 Summary:
Sponsor: Abbott Nutrition

Current Primary Outcome: Physician Perception of Formula Use [ Time Frame: Baseline to Month 6 ]

Questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Abbott Nutrition

Dates:
Date Received: March 18, 2016
Date Started: February 2013
Date Completion:
Last Updated: June 28, 2016
Last Verified: June 2016