Osmolality of Oral Supplements and Ileostomy Output

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ileostomy - Stoma, Short Bowel Syndrome, Sodium Depletion, Nutritional Deficiency

Intervention / Treatment
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* Dietary Supplement: Isoosmolar
* Dietary Supplement: Hyperosmolar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blinded, active comparator, cross-over intervention study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isoosmolar<br>Iso-osmolar oral supplement (276 mOsm/kg) | Dietary Supplement: Isoosmolar<br>* 48 hours, 800 ml per 24 hours<br>|
| Active Comparator: Hyperosmolar<br>Hyper-osmolar oral supplement (681 mOsm/kg) | Dietary Supplement: Hyperosmolar<br>* 48 hours, 800 ml per 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoma output | 24 hour stoma output weight | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urine production | 24 hour urine volume (ml) | 24 hours | 
| 24-hour urinary sodium excretion | 24-hour sodium (mmol) | 24 hours |