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NCT00345566 Clinical Trial

Effect of Protein Composition on Gastric Emptying

Cerebral Palsy Clinical Trial

Official title:
Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00345566
Other study ID # UUSKBK28200706
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 27, 2006
Last updated June 27, 2006
Start date August 2006
Est. completion date December 2007

Study information
Verified date June 2006
Source Ullevaal University Hospital
Contact Groa B Johannesdottir, MD
Phone 004722118765
Email groh@uus.no
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.

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, whey/casein 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 16 Years
Eligibility Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -

Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Nutrition composition

Locations
Country Name City State
Norway Ullevaal university hospital Oslo

Sponsors (2)
Lead Sponsor Collaborator
Ullevaal University Hospital Numico Europe

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric emptying, measured by octanoic acid breath test.
Secondary Electrogastrography
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