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

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.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome; Nutritional Deficiency; Ileostomy; Functional Disturbance; Absorption; Disorder, Protein
• Intervention / Treatment: Dietary supplement: Hydrolysed whey; Dietary supplement: Intact whey; Dietary supplement: Caseinate

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrolysed whey	Dietary supplement: Hydrolysed whey; 500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
Active Comparator: Intact whey	Dietary supplement: Intact whey; 500 mL solution of 25 gram intact whey per day during 4 weeks
Placebo Comparator: Caseinate	Dietary supplement: Caseinate; 500 mL solution of 25 gram casein ate per day during 4 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christian Hvas
• Investigators: Principal Investigator: Christian L Hvas, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): July 13, 2023

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Nutrition Disorders; Intestinal Diseases; Malabsorption Syndromes; Malnutrition; Short Bowel Syndrome
• Other Study ID Numbers: 1-10-72-111-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data or selections herof will be shared upon specific agreements and with researchers who have legitimate causes, following contact to the PI
• IPD Sharing Time Frame: upon request, after publication
• IPD Sharing Access Criteria: contact to PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No