Osmolality of Oral Supplements and Ileostomy Output

Not Applicable

Completed

• Conditions: Ileostomy - Stoma; Nutritional Deficiency; Sodium Depletion; Short Bowel Syndrome
• Interventions: Dietary Supplement: Hyperosmolar; Dietary Supplement: Isoosmolar

• Registration Number: NCT03348709
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Primary Completion: 2018-06-01
• Status Verified: 2018-11
• Study Completion: 2018-11-01
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hyperosmolar	Hyperosmolar	Hyper-osmolar oral supplement (681 mOsm/kg)
Isoosmolar	Isoosmolar	Iso-osmolar oral supplement (276 mOsm/kg)

Primary Outcome Measures

Name	Time	Method
Stoma output	24 hours	24 hour stoma output weight

Secondary Outcome Measures

Name	Time	Method
24-hour urinary sodium excretion	24 hours	24-hour sodium (mmol)
24-hour urine production	24 hours	24 hour urine volume (ml)

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark