Ileostomy - Stoma, Nutritional Deficiency, Short Bowel Syndrome, Sodium Depletion
Conditions
Brief summary
This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight compensated patients with an ileostomy and not on home parenteral Nutrition or fluid support.
Detailed description
Patients with an ileostomy may experience fluid and electrolyte imbalances sedondary to an unregulated intestinal loss of water and electrolytes. The osmolality of oral supplements may affect these losses. In a double-blinded, active comparator, cross-over intervention study, the investigators test the effects of substituting 800 ml of the usual fluid intake with an intake of either an isoosmolar (300 mOsm/kg) or hyperosmolar (700 mOsm/kg) supplement during 48 hours, following baseline data collection before both intervention periods. Outcome measures were stoma output volume, 24-hour urine and urinary sodium excretion, and intestinal aquaporin 3 and 8 expressions.
Interventions
DIETARY_SUPPLEMENTIsoosmolar
48 hours, 800 ml per 24 hours
DIETARY_SUPPLEMENTHyperosmolar
48 hours, 800 ml per 24 hours
Sponsors
University of Copenhagen
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomisation by Third party; Unblinded study nurse to mix and deliver study product; masking of product to ensure comparable palatability and appearance; blinding to analyses
Intervention model description
Double-blinded, active comparator, cross-over intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years or more * ilestomy established 6 weeks or more prior to inclusion * able to drink at least 100 ml fluid per 24 hours * i known inflammatory bowel disease, clinical remission judged by physician's global assessment (PGA) * less than 5 kg self-reported weight change during the past 3 months
Exclusion criteria
* self-reported intolerance to dairy products, including lactose * known renal insufficiency, defined by an eGFR less than 30 ml/min * known diabetes mellitus, defined by an HbA1C \> 48 mmol/mol (6.5%) * current enteral tube feeding or parenteral fluid or Nutrition support more than twice weekly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stoma output | 24 hours | 24 hour stoma output weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour urine production | 24 hours | 24 hour urine volume (ml) |
| 24-hour urinary sodium excretion | 24 hours | 24-hour sodium (mmol) |
Countries
Denmark
Outcome results
None listed