- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345566
Effect of Protein Composition on Gastric Emptying
Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Groa B Johannesdottir, MD
- Phone Number: 004722118765
- Email: groh@uus.no
Study Contact Backup
- Name: Charlotte Brun, MD
- Phone Number: 004722118765
- Email: brap@uus.no
Study Locations
-
-
-
Oslo, Norway, 0407
- Ullevaal University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -
Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Gastric emptying, measured by octanoic acid breath test.
|
Secondary Outcome Measures
Outcome Measure |
---|
Electrogastrography
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Ketil Stordal, PHD
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UUSKBK28200706
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Nutrition composition
-
University of Kansas Medical CenterNot yet recruitingResting Metabolic Rate | Post Operative Nutrition | Metabolism; Disorder, Postprocedural
-
David BaerNational Institute on Deafness and Other Communication Disorders (NIDCD); Monell...Active, not recruiting
-
Tufts Medical CenterCompleted
-
University of California, Los AngelesCompletedHeart Failure | ObesityUnited States
-
United States Army Research Institute of Environmental...Recruiting
-
University of MinnesotaBaystate Medical Center; Santa Clara Valley Medical CenterCompletedPreterm Birth
-
Northumbria UniversityCompleted
-
Hvidovre University HospitalUniversity of Copenhagen; Danish Research Centre for Magnetic ResonanceRecruitingDiabetes Mellitus, Type 2 | Metabolic Syndrome | Overweight and Obesity | Non-Alcoholic Fatty Liver DiseaseDenmark
-
Medical University of ViennaUnknownBody Composition | UltrasoundAustria
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedSubstance-Related Disorders | Tobacco Use DisorderUnited States