NCT03348709

Osmolality of Oral Supplements and Ileostomy Output

Does Osmolality of Oral Supplements Affect Stoma Output and Natriuresis in Patients With an Ileostomy?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ileostomy - Stoma
• Short Bowel Syndrome
• Sodium Depletion
• Nutritional Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Isoosmolar	48 hours, 800 ml per 24 hours
DIETARY_SUPPLEMENT	Hyperosmolar	48 hours, 800 ml per 24 hours

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-06-01
• Completion: 2018-11-01
• First posted: 2017-11-21
• Last updated: 2018-11-05

Locations

1 site across 1 country: Denmark