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Effect of Protein Composition on Gastric Emptying

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00345566
Enrollment
25
Registered
2006-06-28
Start date
2006-08-31
Completion date
2007-12-31
Last updated
2006-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Enteral Feeding, Gastric Dysmotility

Keywords

cerebral palsy, protein composition, gastric emptying rate, tube feeding

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.

Interventions

PROCEDURENutrition composition

Sponsors

Numico Europe
CollaboratorUNKNOWN
Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

Cerebral paresis, user of tube feedings through gastrostomy -

Exclusion criteria

Use of valproic acid (interferes with breath test). Age \>16 y. \-

Design outcomes

Primary

MeasureTime frame
Gastric emptying, measured by octanoic acid breath test.

Secondary

MeasureTime frame
Electrogastrography

Countries

Norway

Contacts

Primary ContactGroa B Johannesdottir, MD
groh@uus.no004722118765
Backup ContactCharlotte Brun, MD
brap@uus.no004722118765

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026