Osmolality of Oral Supplements and Ileostomy Output

University of Aarhus8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ileostomy - Stoma Short Bowel Syndrome Sodium Depletion Nutritional Deficiency

Interventions

IsoosmolarDIETARY_SUPPLEMENT

48 hours, 800 ml per 24 hours

HyperosmolarDIETARY_SUPPLEMENT

48 hours, 800 ml per 24 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital

Aarhus C, Denmark

Outcomes

Primary Outcomes

Stoma output

24 hour stoma output weight

Time frame: 24 hours

Secondary Outcomes

24-hour urine production

24 hour urine volume (ml)

Time frame: 24 hours

24-hour urinary sodium excretion

24-hour sodium (mmol)

Time frame: 24 hours

Data from ClinicalTrials.gov

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