Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-10-31

Brief Summary

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Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy

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Detailed Description

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14 patients with ileostomies were included in a quasi-randomized, crossover intervention study. Each patient ingested between 3-18 different supplements during separate 6-hours intervention periods. Ileostomy output and urine volume will be collected. Outcome measures include faecal wet-weight, urine volume, electrolytes, osmolality, and body composition measured with bioelectrical impedance analysis.

Conditions

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Ileostomy - Stoma Intestinal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This was a single-centre, quasi-randomised cross-over intervention study. The effects of osmolality in oral supplements were investigated using a 3x3 cross-over design.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

The patients were randomised to receive either the hypo-osmolar or hyper-osmolar in their first intervention. Microsoft Excel feature "RAND" (Microsoft version 16) was used to randomize oral supplements. Each supplement was assigned a number. Every time a patient agreed to one or two more intervention periods, two supplements were randomized. One of the primary investigators (JQ) enrolled and randomized supplements to the patients

Study Groups

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hypoosmolar

One with a hypo-osmolar fluid

Group Type ACTIVE_COMPARATOR