Osmolality of Oral Supplements and Ileostomy Output

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

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma; Short Bowel Syndrome; Nutritional Deficiency; Sodium Depletion
• Intervention / Treatment: Dietary supplement: Isoosmolar; Dietary supplement: Hyperosmolar

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Copenhagen
• Investigators: Study Chair: Hendrik Vilstrup, Professor, University of Aarhus

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Nutrition Disorders; Intestinal Diseases; Malabsorption Syndromes; Malnutrition; Short Bowel Syndrome
• Other Study ID Numbers: 1-10-72-12-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication of anonymised data. Data backup in accessible data platform.
• IPD Sharing Time Frame: During last 6 months of study period, 10 years
• IPD Sharing Access Criteria: established researcher
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No