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Osmolality of Oral Supplements and Ileostomy Output

Primary Purpose

Ileostomy - Stoma, Short Bowel Syndrome, Sodium Depletion

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Isoosmolar
Hyperosmolar
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ileostomy - Stoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isoosmolar

Hyperosmolar

Arm Description

Iso-osmolar oral supplement (276 mOsm/kg)

Hyper-osmolar oral supplement (681 mOsm/kg)

Outcomes

Primary Outcome Measures

Stoma output
24 hour stoma output weight

Secondary Outcome Measures

24-hour urine production
24 hour urine volume (ml)
24-hour urinary sodium excretion
24-hour sodium (mmol)

Full Information

First Posted
November 16, 2017
Last Updated
November 2, 2018
Sponsor
University of Aarhus
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03348709
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileostomy - Stoma, Short Bowel Syndrome, Sodium Depletion, Nutritional Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double-blinded, active comparator, cross-over intervention study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomisation by Third party; Unblinded study nurse to mix and deliver study product; masking of product to ensure comparable palatability and appearance; blinding to analyses
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isoosmolar
Arm Type
Experimental
Arm Description
Iso-osmolar oral supplement (276 mOsm/kg)
Arm Title
Hyperosmolar
Arm Type
Active Comparator
Arm Description
Hyper-osmolar oral supplement (681 mOsm/kg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Isoosmolar
Intervention Description
48 hours, 800 ml per 24 hours
Intervention Type
Dietary Supplement
Intervention Name(s)
Hyperosmolar
Intervention Description
48 hours, 800 ml per 24 hours
Primary Outcome Measure Information:
Title
Stoma output
Description
24 hour stoma output weight
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
24-hour urine production
Description
24 hour urine volume (ml)
Time Frame
24 hours
Title
24-hour urinary sodium excretion
Description
24-hour sodium (mmol)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Vilstrup, Professor
Organizational Affiliation
University of Aarhus
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30396772
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.
Results Reference
derived

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Osmolality of Oral Supplements and Ileostomy Output

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