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GI tolerance study in critically ill model (CIM)

Effect of composition of enteral feeding on gastric content volume during continuous feeding: a randomized cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27330
Enrollment
20
Registered
2017-05-17
Start date
2017-03-31
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Gastrointestinal tolerance in healthy volunteers in which gastric conditions of critically ill patients will be mimicked by medication.

Interventions

Duration of intervention: 4 hours Intervention product: whey dominant tube feed Control product: casein dominant tube feed

Sponsors

Nutricia Research B.V. Uppsalalaan 12, 3508 CT Utrecht – the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Main 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 criteria

Exclusion criteria: Main 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

Design outcomes

Primary

MeasureTime frame
Gastric content volume

Secondary

MeasureTime frame
Plasma amino acid concentrations

Contacts

Public ContactPeter van Horssen

PO box. 80141

Peter.vanhorssen@nutricia.comT: +31 (0)30 2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)