Osmolality of Oral Supplements and Ileostomy Output

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348709
• Other study ID #: 1-10-72-12-17
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: November 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyponatremia
• Ileostomy - Stoma
• Malnutrition
• Nutritional Deficiency
• Short Bowel Syndrome
• Sodium Depletion

Intervention

Dietary Supplement:
• Isoosmolar
48 hours, 800 ml per 24 hours
• Hyperosmolar
48 hours, 800 ml per 24 hours

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stoma output	24 hour stoma output weight	24 hours
Secondary	24-hour urine production	24 hour urine volume (ml)	24 hours
Secondary	24-hour urinary sodium excretion	24-hour sodium (mmol)	24 hours