Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy (NCT04141826) | Clinical Trial Compass
CompletedNot Applicable
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
Denmark14 participantsStarted 2020-01-27
Plain-language summary
Clinical trial, active comparator, cross over, randomised. In total, 12 adults with an ileostomy will be randomised to a sequential 4 weeks intervention with different qualities and sources of protein wish 2-week washout periods. Primary outcome: Ileostomy output.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (≥ 18 years old), male or female patients with an ileostomy and intestinal insufficiency
* 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:
* Parenteral nutrition or intravenous fluid support ≥ 4000 mL/month
* 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