Status:
COMPLETED
Osmolality of Oral Supplements and Ileostomy Output
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
University of Copenhagen
Conditions:
Ileostomy - Stoma
Short Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 aquapor...
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 lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03348709
Start Date
June 1 2017
End Date
November 1 2018
Last Update
November 5 2018
Active Locations (1)
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1
Aarhus University Hospital
Aarhus C, Denmark, 8000