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GI tolerance study in critically ill model (CIM)


- candidate number27230
- NTR NumberNTR6423
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2017
- Secondary IDsS59976 Commissie Medische Ethiek UZ KU Leuven
- Public TitleGI tolerance study in critically ill model (CIM)
- Scientific TitleEffect of composition of enteral feeding on gastric content volume during continuous feeding: a randomized cross-over study
- ACRONYMCIM study
- hypothesisIt is hypothesized that the outcome of the primary outcome parameter will be different for the test product compared to the control product.
- Healt Condition(s) or Problem(s) studiedGastrointestinal tolerance
- Inclusion criteriaMain inclusion criteria
1. Age between 18 and 50 (including 18 and 50) years
2. Being in good health as to the judgement of the investigator
3. Written informed consent
- Exclusion criteriaMain exclusion criteria
1. Known history of any disorders such as; gastrointestinal (GI), cardiovascular, respiratory, hematological, renal, hepatic, hypothyroidism, psychiatric panic attacks and/or diabetes mellitus and/or a history of brain tumor, an enlarged prostate or urination problems and/or recent head injury
2. Presence of implants, devices, or metallic foreign bodies interacting with MRI
3. A low systolic blood pressure (<100 mm Hg) in supine position
4. Pregnancy or breastfeeding
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 31-mrt-2017
- planned closingdate1-jun-2019
- Target number of participants20
- InterventionsDuration of intervention: 4 hours
Intervention product: whey dominant tube feed
Control product: casein dominant tube feed
- Primary outcomeGastric content volume
- Secondary outcomePlasma amino acid concentrations
- TimepointsV0 (screening day -21 until day -4); V1 (day 1); V2 (day 15)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESSr. Peter van Horssen
- CONTACT for SCIENTIFIC QUERIES Dina Ripken
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsPending
- Brief summaryThis study will investigate the effect of composition of enteral feeding on gastric content volume during continuous feeding. The study will be a randomized, controlled, open label, cross-over, single centre study. The study will be performed in healthy volunteers in which gastric conditions of critically ill patients will be mimicked by medication. Subjects will be continuously fed for 4-hours with the intervention product (whey dominant tube feed) or control product (casein dominant tube feed). Before, during and after feeding the gastric content volume will be studied.
- Main changes (audit trail)
- RECORD17-mei-2017 - 26-jun-2017


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