Cerebral PalsyNCT00345566
Effect of Protein Composition on Gastric Emptying
A study testing Nutrition composition in people with Cerebral Palsy and Gastric Dysmotility, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Cerebral Palsy, Gastric Dysmotility, Enteral Feeding
- What is being tested?
- Nutrition composition
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -
Exclusion Criteria: Use of valproic acid (interferes with breath test). Age >16 y.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis
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.
Read the 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.
- Conditions
- Cerebral Palsy, Gastric Dysmotility, Enteral Feeding
- Being tested
- Nutrition composition
- Keywords
- cerebral palsy, protein composition, gastric emptying rate, tube feeding
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition compositionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying, measured by octanoic acid breath test.
Secondary outcomes (1)
Electrogastrography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startAug 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Numico Europe
- Investigators
- Ketil Stordal, PHD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345566
- Sponsor's protocol ID
- UUSKBK28200706
- Status last verified
- Jun 2006
- First submitted
- 27 Jun 2006
- Last updated
- 28 Jun 2006
- Results posted
- No
Publications
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.
PubMed 23196118
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis
- ClinicalTrials.gov ID
- NCT00345566
- Acronym / sponsor ID
- UUSKBK28200706
- Conditions
- Cerebral Palsy, Gastric Dysmotility, Enteral Feeding
- Keywords
- cerebral palsy, protein composition, gastric emptying rate, tube feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Numico Europe
- Study start
- Aug 2006
- Study completion
- Dec 2007
- First posted
- 28 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition composition | Procedure or surgery | – |
Primary outcome
Gastric emptying, measured by octanoic acid breath test.
1 secondary outcome
Electrogastrography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2006.
- Derived from this study: PubMed 23196118Brun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketil Stordal, PHD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition composition in people with Cerebral Palsy and Gastric Dysmotility, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Groa B Johannesdottir, MD (004722118765, groh@uus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying, measured by octanoic acid breath test.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2006.