Ileostomy - StomaNCT03348709
Osmolality of Oral Supplements and Ileostomy Output
A study testing Isoosmolar and Hyperosmolar in people with Ileostomy - Stoma and Short Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma, Short Bowel Syndrome, Sodium Depletion
- What is being tested?
- Isoosmolar and Hyperosmolar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Isoosmolar, Hyperosmolar
- Medical subject headings
- Short Bowel Syndrome, Hyponatremia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoosmolarDietary supplement
48 hours, 800 ml per 24 hours
HyperosmolarDietary supplement
48 hours, 800 ml per 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Isoosmolar | Experimental | Iso-osmolar oral supplement (276 mOsm/kg) Receives: Dietary Supplement: Isoosmolar |
| Hyperosmolar | Active comparator | Hyper-osmolar oral supplement (681 mOsm/kg) Receives: Dietary Supplement: Hyperosmolar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma output
24 hour stoma output weight
Measured: 24 hours
Secondary outcomes (2)
24-hour urine production
24 hour urine volume (ml)
Measured: 24 hours
24-hour urinary sodium excretion
24-hour sodium (mmol)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, active comparator, cross-over intervention study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Christian Hvas, University of Aarhus
- Investigators
- Hendrik Vilstrup, Professor, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348709
- Sponsor's protocol ID
- 1-10-72-12-17
- Status last verified
- Nov 2018
- First submitted
- 16 Nov 2017
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of anonymised data. Data backup in accessible data platform.
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.
PubMed 30396772
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Osmolality of Oral Supplements Affect Stoma Output and Natriuresis in Patients With an Ileostomy?
- ClinicalTrials.gov ID
- NCT03348709
- Acronym / sponsor ID
- 1-10-72-12-17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, active comparator, cross-over intervention study
| Arm | Type | Receives |
|---|---|---|
| Isoosmolar | Experimental | Dietary Supplement: IsoosmolarIso-osmolar oral supplement (276 mOsm/kg) |
| Hyperosmolar | Active comparator | Dietary Supplement: HyperosmolarHyper-osmolar oral supplement (681 mOsm/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoosmolar48 hours, 800 ml per 24 hours | Dietary supplement | Isoosmolar |
| Hyperosmolar48 hours, 800 ml per 24 hours | Dietary supplement | Hyperosmolar |
Primary outcome
Stoma output
Time frame: 24 hours
24 hour stoma output weight
2 secondary outcomes
24-hour urine production
Time frame: 24 hours
24-hour urinary sodium excretion
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Derived from this study: PubMed 30396772Rud 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.
- Individual participant dataSharing planned: Yes. Publication of anonymised data. Data backup in accessible data platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Vilstrup, Professor study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoosmolar and Hyperosmolar in people with Ileostomy - Stoma and Short Bowel Syndrome, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoma output (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.