Aarhus University Hospital
Aarhus N, 8200, Denmark
NCT Number: NCT04141826
Clinical trial, active comparator, cross over, randomised. In total, 12 adults with an ileostomy will be randomised to a sequential 4 weeks intervention with different qualities and sources of protein wish 2-week washout periods. Primary outcome: Ileostomy output.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aarhus N, 8200, Denmark
Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
500 mL solution of 25 gram intact whey per day during 4 weeks
500 mL solution of 25 gram casein ate per day during 4 weeks
Time frame: 4 weeks
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
Time frame: 4 weeks
24 hour urine volume
Time frame: 4 weeks
24 hour urine sodium excretion
Time frame: 6 hours
Plasma amino acids
Time frame: 6 hours
3D transit evaluation
Time frame: 6 hours
Intestinal hormones during absorption
Time frame: 4 weeks
Pen and paper test, score with range
Time frame: 4 weeks
Pen and paper test, score with range
Time frame: 4 weeks
Reaction to 150 sound stimuli, read-out as index compared to normal values
Time frame: 4 weeks
Telemetric sensor
Time frame: 4 weeks
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Bio-impedance analysis (SECA)
Christian Hvas
Other
Acronym: ABSOLYT
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