Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
NCT ID: NCT04141826
Last Updated: 2024-03-04
Study Results
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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COMPLETED
NA
14 participants
INTERVENTIONAL
2020-01-27
2023-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Hydrolysed whey
Hydrolysed whey
Hydrolysed whey
500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
Intact whey
Intact whey
Intact whey
500 mL solution of 25 gram intact whey per day during 4 weeks
Caseinate
Caseinate
Caseinate
500 mL solution of 25 gram casein ate per day during 4 weeks
Interventions
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Hydrolysed whey
500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
Intact whey
500 mL solution of 25 gram intact whey per day during 4 weeks
Caseinate
500 mL solution of 25 gram casein ate per day during 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Episodical or chronic sodium depletion defined by two urine samples with sodium levels ≤ 20 mmol/L, sampled with at least 28 days apart
* Six months or more after most recent bowel surgery
* If inflammatory bowel disease, no clinical signs of activity (any treatment allowed except systemic steroids \> 10 mg/day)
Exclusion Criteria
* Ongoing infection (C-reactive protein above 8 mg/L or core temperature \>38.0°C)
* Self-reported intolerance to dairy products, including lactose intolerance
* Inability to understand Danish or the trial procedures
* Known or anticipated pregnancy
* Known severe renal insufficiency (eGFR \< 20 mL/min)
* Known diabetes mellitus (HbA1c ≥ 48 mmol/mol (6.5%))
* Pacemaker, cochlear implants, or other electrical implants excludes the participants from BIA-measurements and measurements of GITT with 3D-Transit capsules, but not the remaining investigations
* Known intestinal stenosis or parastomal hernia excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
* Abdominal diameter \> 140 cm, or planned MR scan four weeks following participation excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
18 Years
ALL
Yes
Sponsors
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Christian Hvas
OTHER
Responsible Party
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Christian Hvas
Consultant, associate professor
Principal Investigators
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Christian L Hvas, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus N, , Denmark
Countries
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References
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Rud CL, Hvistendahl MK, Langdahl B, Kraglund F, Baunwall SMD, Lal S, Jeppesen PB, Hvas CL. Protein-based oral rehydration solutions for patients with an ileostomy: A randomised, double-blinded crossover study. Clin Nutr. 2024 Jul;43(7):1747-1758. doi: 10.1016/j.clnu.2024.05.038. Epub 2024 May 28.
Other Identifiers
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1-10-72-111-19
Identifier Type: -
Identifier Source: org_study_id
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