Osmolality of Oral Supplements and Ileostomy Output

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-11-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ileostomy - Stoma Short Bowel Syndrome Sodium Depletion Nutritional Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blinded, active comparator, cross-over intervention study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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Isoosmolar

Iso-osmolar oral supplement (276 mOsm/kg)

Group Type EXPERIMENTAL

Isoosmolar

Intervention Type DIETARY_SUPPLEMENT

48 hours, 800 ml per 24 hours

Hyperosmolar

Hyper-osmolar oral supplement (681 mOsm/kg)

Group Type ACTIVE_COMPARATOR

Hyperosmolar

Intervention Type DIETARY_SUPPLEMENT

48 hours, 800 ml per 24 hours

Interventions

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Isoosmolar

48 hours, 800 ml per 24 hours

Intervention Type DIETARY_SUPPLEMENT

Hyperosmolar

48 hours, 800 ml per 24 hours

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No