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Effect of Protein Composition on Gastric Emptying

U

Ullevaal University Hospital

Status

Unknown

Conditions

Enteral Feeding
Cerebral Palsy
Gastric Dysmotility

Treatments

Procedure: Nutrition composition

Study type

Interventional

Funder types

Other

Identifiers

NCT00345566
UUSKBK28200706

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Charlotte Brun, MD; Groa B Johannesdottir, MD

Data sourced from clinicaltrials.gov

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