search
Back to results

Effect of Protein Composition on Gastric Emptying

Primary Purpose

Cerebral Palsy, Gastric Dysmotility, Enteral Feeding

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nutrition composition
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, protein composition, gastric emptying rate, tube feeding

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy - Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y. -

Sites / Locations

  • Ullevaal university hospital

Outcomes

Primary Outcome Measures

Gastric emptying, measured by octanoic acid breath test.

Secondary Outcome Measures

Electrogastrography

Full Information

First Posted
June 27, 2006
Last Updated
June 27, 2006
Sponsor
Ullevaal University Hospital
Collaborators
Numico Europe
search

1. Study Identification

Unique Protocol Identification Number
NCT00345566
Brief Title
Effect of Protein Composition on Gastric Emptying
Official Title
Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
Numico Europe

4. Oversight

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Gastric Dysmotility, Enteral Feeding
Keywords
cerebral palsy, protein composition, gastric emptying rate, tube feeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Nutrition composition
Primary Outcome Measure Information:
Title
Gastric emptying, measured by octanoic acid breath test.
Secondary Outcome Measure Information:
Title
Electrogastrography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy - Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Groa B Johannesdottir, MD
Phone
004722118765
Email
groh@uus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Brun, MD
Phone
004722118765
Email
brap@uus.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketil Stordal, PHD
Official's Role
Study Chair
Facility Information:
Facility Name
Ullevaal university hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
23196118
Citation
Brun AC, Stordal K, Johannesdottir GB, Fossum V, Bentsen BS, Medhus AW. Nissen fundoplication in children with cerebral palsy: influence on rate of gastric emptying and postprandial symptoms in relation to protein source in caloric liquid meals. Clin Nutr. 2013 Aug;32(4):619-23. doi: 10.1016/j.clnu.2012.11.010. Epub 2012 Nov 17.
Results Reference
derived

Learn more about this trial

Effect of Protein Composition on Gastric Emptying

We'll reach out to this number within 24 hrs