Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome, Absorption; Disorder, Protein
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHydrolysed whey
500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
DIETARY_SUPPLEMENTIntact whey
500 mL solution of 25 gram intact whey per day during 4 weeks
DIETARY_SUPPLEMENTCaseinate
500 mL solution of 25 gram casein ate per day during 4 weeks
Sponsors
Christian Hvas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Production in separate facility, randomisation key kept by third party
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult (≥ 18 years old), male or female patients with an ileostomy and intestinal insufficiency * Episodical or chronic sodium depletion defined by two urine samples with sodium levels ≤ 20 mmol/L, sampled with at least 28 days apart * Six months or more after most recent bowel surgery * If inflammatory bowel disease, no clinical signs of activity (any treatment allowed except systemic steroids \> 10 mg/day)
Exclusion criteria
* Parenteral nutrition or intravenous fluid support ≥ 4000 mL/month * Ongoing infection (C-reactive protein above 8 mg/L or core temperature \>38.0°C) * Self-reported intolerance to dairy products, including lactose intolerance * Inability to understand Danish or the trial procedures * Known or anticipated pregnancy * Known severe renal insufficiency (eGFR \< 20 mL/min) * Known diabetes mellitus (HbA1c ≥ 48 mmol/mol (6.5%)) * Pacemaker, cochlear implants, or other electrical implants excludes the participants from BIA-measurements and measurements of GITT with 3D-Transit capsules, but not the remaining investigations * Known intestinal stenosis or parastomal hernia excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations * Abdominal diameter \> 140 cm, or planned MR scan four weeks following participation excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour fecal wet weight | 4 weeks | Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natriuresis | 4 weeks | 24 hour urine sodium excretion |
| Amino acid absorption | 6 hours | Plasma amino acids |
| Gastric and small bowel emptying | 6 hours | 3D transit evaluation |
| GLP1 and GLP2 | 6 hours | Intestinal hormones during absorption |
| Portosystemic hepatic encephalopathy (PSE) test score, median value | 4 weeks | Pen and paper test, score with range |
| Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4) | 4 weeks | Pen and paper test, score with range |
| Continuous reaction time (CRT) index median | 4 weeks | Reaction to 150 sound stimuli, read-out as index compared to normal values |
| Diuresis | 4 weeks | 24 hour urine volume |
| Body weight (kg) | 4 weeks | Bio-impedance analysis (SECA) |
| Total body water (L) | 4 weeks | Bio-impedance analysis (SECA) |
| Extracellular water (L) | 4 weeks | Bio-impedance analysis (SECA) |
| Skeletal muscle mass (kg) | 4 weeks | Bio-impedance analysis (SECA) |
| Fat-free mass (kg) | 4 weeks | Bio-impedance analysis (SECA) |
| Fat mass (kg) | 4 weeks | Bio-impedance analysis (SECA) |
| Physical activity | 4 weeks | Telemetric sensor |
Countries
Denmark
Outcome results
None listed