Clinical trial NCT03348709: Osmolality of Oral Supplements and Ileostomy Output
Official title: Does Osmolality of Oral Supplements Affect Stoma Output and Natriuresis in Patients With an Ileostomy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Short Bowel Syndrome
Sodium Depletion
Nutritional Deficiency
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2017-11-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded, active comparator, cross-over intervention study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stoma output
timeFrame: 24 hours
Secondary outcomes:
measure: 24-hour urine production
timeFrame: 24 hours
measure: 24-hour urinary sodium excretion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Hendrik Vilstrup, Professor
role: STUDY_CHAIR
References:
citation: Rud C, Pedersen AKN, Wilkens TL, Borre M, Andersen JR, Moeller HB, Dahlerup JF, Hvas CL. An iso-osmolar oral supplement increases natriuresis and does not increase stomal output in patients with an ileostomy: A randomised, double-blinded, active comparator, crossover intervention study. Clin Nutr. 2019 Oct;38(5):2079-2086. doi: 10.1016/j.clnu.2018.10.014. Epub 2018 Oct 24.