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Completed

NCT Number: NCT03348709

Osmolality of Oral Supplements and Ileostomy Output

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoosmolar

Dietary Supplement

48 hours, 800 ml per 24 hours

Hyperosmolar

Dietary Supplement

48 hours, 800 ml per 24 hours

Primary outcomes

  1. Stoma output

    Time frame: 24 hours

    24 hour stoma output weight

Secondary outcomes

  1. 24-hour urine production

    Time frame: 24 hours

    24 hour urine volume (ml)

  2. 24-hour urinary sodium excretion

    Time frame: 24 hours

    24-hour sodium (mmol)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2017
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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