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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
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
Aarhus University Hospital
Aarhus N, Denmark
24-hour fecal wet weight
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
Time frame: 4 weeks
Diuresis
24 hour urine volume
Time frame: 4 weeks
Natriuresis
24 hour urine sodium excretion
Time frame: 4 weeks
Amino acid absorption
Plasma amino acids
Time frame: 6 hours
Gastric and small bowel emptying
3D transit evaluation
Time frame: 6 hours
GLP1 and GLP2
Intestinal hormones during absorption
Time frame: 6 hours
Portosystemic hepatic encephalopathy (PSE) test score, median value
Pen and paper test, score with range
Time frame: 4 weeks
Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)
Pen and paper test, score with range
Time frame: 4 weeks
Continuous reaction time (CRT) index median
Reaction to 150 sound stimuli, read-out as index compared to normal values
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Physical activity
Telemetric sensor
Time frame: 4 weeks
Body weight (kg)
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Total body water (L)
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Extracellular water (L)
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Skeletal muscle mass (kg)
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Fat-free mass (kg)
Bio-impedance analysis (SECA)
Time frame: 4 weeks
Fat mass (kg)
Bio-impedance analysis (SECA)
Time frame: 4 weeks