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Effect of Protein Composition on Gastric Emptying

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Ullevaal University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345566
First Posted: June 28, 2006
Last Update Posted: June 28, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Numico Europe
Information provided by:
Ullevaal University Hospital
  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
Intervention Model: Crossover Assignment
Masking: Double
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:


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

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00345566     History of Changes
Other Study ID Numbers: UUSKBK28200706
First Submitted: June 27, 2006
First Posted: June 28, 2006
Last Update Posted: June 28, 2006
Last Verified: June 2006

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