Viewing Study NCT00345566



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Study NCT ID: NCT00345566
Status: UNKNOWN
Last Update Posted: 2006-06-28
First Post: 2006-06-27

Brief Title: Effect of Protein Composition on Gastric Emptying
Sponsor: Ullevaal University Hospital
Organization: Ullevaal University Hospital

Study Overview

Official Title: Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis
Status: UNKNOWN
Status Verified Date: 2006-06
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology This is espesially important in children with neurologic impariment who commonly rely on tube feedings have feeding problems nausea vomiting gastroesophageal reflux and delayed gastric emptying We aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children
Detailed Description: Several factors in nutrition are known to affect gastric emptying rate such as energy content temperature viscosity etc In infants the protein composition affects gastric emptying Children with cerebral pasly commonly have foregut dysmotility - with nausea vomiting feeding intolerance and gastroesophageal reflux Tube feedings usually based on cows milk are commonly used

Our hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology

Using four different tube feedings standardized for content of fat glucose and calories we will measure gastric emptying rate using C13 octanoic acid as well as electrogastrography will be recorded The protein modules are derived from casein wheycasein mixture hydrolyzed whey and aminoacids Children with cerebral paresis and gastrostomy will be included Each serves as his her own control

The primary endpoint is gastric emptying rate the secondary endpoint electrogastrography

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None