Clinical trial NCT04141826: Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
Official title: Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Ileostomy; Functional Disturbance
Short Bowel Syndrome
Absorption; Disorder, Protein
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.

Eligibility criteria: 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

Primary outcomes:
measure: 24-hour fecal wet weight
timeFrame: 4 weeks
Secondary outcomes:
measure: Diuresis
timeFrame: 4 weeks
measure: Natriuresis
timeFrame: 4 weeks
measure: Amino acid absorption
timeFrame: 6 hours
measure: Gastric and small bowel emptying
timeFrame: 6 hours
measure: GLP1 and GLP2
timeFrame: 6 hours
measure: Portosystemic hepatic encephalopathy (PSE) test score, median value
timeFrame: 4 weeks
measure: Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)
timeFrame: 4 weeks
measure: Continuous reaction time (CRT) index median
timeFrame: 4 weeks
measure: Physical activity
timeFrame: 4 weeks
measure: Body weight (kg)
timeFrame: 4 weeks
measure: Total body water (L)
timeFrame: 4 weeks
measure: Extracellular water (L)
timeFrame: 4 weeks
measure: Skeletal muscle mass (kg)
timeFrame: 4 weeks
measure: Fat-free mass (kg)
timeFrame: 4 weeks
measure: Fat mass (kg)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Christian L Hvas, PhD
role: PRINCIPAL_INVESTIGATOR
References: