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

Short Bowel Syndrome Clinical Trial

— ABSOLYT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141826
• Other study ID #: 1-10-72-111-19
• Status: Completed
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: July 13, 2023

Study information

• Verified date: March 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 13, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Christian Hvas

Country where clinical trial is conducted

Denmark, 

Outcome

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