Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy

Conditions
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Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome, Absorption; Disorder, Protein

Intervention / Treatment
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* Dietary Supplement: Hydrolysed whey
* Dietary Supplement: Intact whey
* Dietary Supplement: Caseinate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrolysed whey<br>Hydrolysed whey | Dietary Supplement: Hydrolysed whey<br>* 500 mL solution of 25 gram hydrolysed whey per day during 4 weeks<br>|
| Active Comparator: Intact whey<br>Intact whey | Dietary Supplement: Intact whey<br>* 500 mL solution of 25 gram intact whey per day during 4 weeks<br>|
| Placebo Comparator: Caseinate<br>Caseinate | Dietary Supplement: Caseinate<br>* 500 mL solution of 25 gram casein ate per day during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour fecal wet weight | Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diuresis | 24 hour urine volume | 4 weeks | 
| Natriuresis | 24 hour urine sodium excretion | 4 weeks | 
| Amino acid absorption | Plasma amino acids | 6 hours | 
| Gastric and small bowel emptying | 3D transit evaluation | 6 hours | 
| GLP1 and GLP2 | Intestinal hormones during absorption | 6 hours | 
| Portosystemic hepatic encephalopathy (PSE) test score, median value | Pen and paper test, score with range | 4 weeks | 
| Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4) | Pen and paper test, score with range | 4 weeks | 
| Continuous reaction time (CRT) index median | Reaction to 150 sound stimuli, read-out as index compared to normal values | 4 weeks | 
| Physical activity | Telemetric sensor | 4 weeks | 
| Body weight (kg) | Bio-impedance analysis (SECA) | 4 weeks | 
| Total body water (L) | Bio-impedance analysis (SECA) | 4 weeks | 
| Extracellular water (L) | Bio-impedance analysis (SECA) | 4 weeks | 
| Skeletal muscle mass (kg) | Bio-impedance analysis (SECA) | 4 weeks | 
| Fat-free mass (kg) | Bio-impedance analysis (SECA) | 4 weeks | 
| Fat mass (kg) | Bio-impedance analysis (SECA) | 4 weeks |