CompletedNot Applicable

Osmolality of Oral Supplements and Ileostomy Output

Denmark8 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stoma output

Timeframe: 24 hours

Trial details

NCT IDNCT03348709

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-01

View on ClinicalTrials.gov More Ileostomy - Stoma trials