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Effect of Protein Composition on Gastric Emptying

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Ullevaal University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Numico Europe
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00345566
First received: June 27, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Cerebral Palsy
Gastric Dysmotility
Enteral Feeding
 Procedure: Nutrition composition

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Gastric emptying, measured by octanoic acid breath test.

Secondary Outcome Measures:
  • Electrogastrography

Estimated Enrollment: 25
Study Start Date: August 2006
Estimated Study Completion Date: December 2007
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, 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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345566

Contacts
Contact: Groa B Johannesdottir, MD 004722118765 groh@uus.no
Contact: Charlotte Brun, MD 004722118765 brap@uus.no

Locations
Norway
Ullevaal university hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Numico Europe
Investigators
Study Chair: Ketil Stordal, PHD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00345566     History of Changes
Other Study ID Numbers: UUSKBK28200706
Study First Received: June 27, 2006
Last Updated: June 27, 2006
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Ullevaal University Hospital:
cerebral palsy
protein composition
gastric emptying rate
tube feeding

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013