Back to resultsAbsorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy (ABSOLYT)
Primary Purpose
Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hydrolysed whey
Intact whey
Caseinate
Sponsored by
About this trial
This is an interventional treatment trial for Nutritional Deficiency
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
Sites / Locations
- Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Hydrolysed whey
Intact whey
Caseinate
Arm Description
Hydrolysed whey
Intact whey
Caseinate
Outcomes
Primary Outcome Measures
24-hour fecal wet weight
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
Secondary Outcome Measures
Diuresis
24 hour urine volume
Natriuresis
24 hour urine sodium excretion
Amino acid absorption
Plasma amino acids
Gastric and small bowel emptying
3D transit evaluation
GLP1 and GLP2
Intestinal hormones during absorption
Portosystemic hepatic encephalopathy (PSE) test score, median value
Pen and paper test, score with range
Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)
Pen and paper test, score with range
Continuous reaction time (CRT) index median
Reaction to 150 sound stimuli, read-out as index compared to normal values
Physical activity
Telemetric sensor
Body weight (kg)
Bio-impedance analysis (SECA)
Total body water (L)
Bio-impedance analysis (SECA)
Extracellular water (L)
Bio-impedance analysis (SECA)
Skeletal muscle mass (kg)
Bio-impedance analysis (SECA)
Fat-free mass (kg)
Bio-impedance analysis (SECA)
Fat mass (kg)
Bio-impedance analysis (SECA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04141826
Brief Title
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
Acronym
ABSOLYT
Official Title
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christian Hvas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency, Ileostomy; Functional Disturbance, Short Bowel Syndrome, Absorption; Disorder, Protein
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Production in separate facility, randomisation key kept by third party
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrolysed whey
Arm Type
Experimental
Arm Description
Hydrolysed whey
Arm Title
Intact whey
Arm Type
Active Comparator
Arm Description
Intact whey
Arm Title
Caseinate
Arm Type
Placebo Comparator
Arm Description
Caseinate
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolysed whey
Intervention Description
500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Intact whey
Intervention Description
500 mL solution of 25 gram intact whey per day during 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Caseinate
Intervention Description
500 mL solution of 25 gram casein ate per day during 4 weeks
Primary Outcome Measure Information:
Title
24-hour fecal wet weight
Description
Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Diuresis
Description
24 hour urine volume
Time Frame
4 weeks
Title
Natriuresis
Description
24 hour urine sodium excretion
Time Frame
4 weeks
Title
Amino acid absorption
Description
Plasma amino acids
Time Frame
6 hours
Title
Gastric and small bowel emptying
Description
3D transit evaluation
Time Frame
6 hours
Title
GLP1 and GLP2
Description
Intestinal hormones during absorption
Time Frame
6 hours
Title
Portosystemic hepatic encephalopathy (PSE) test score, median value
Description
Pen and paper test, score with range
Time Frame
4 weeks
Title
Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)
Description
Pen and paper test, score with range
Time Frame
4 weeks
Title
Continuous reaction time (CRT) index median
Description
Reaction to 150 sound stimuli, read-out as index compared to normal values
Time Frame
4 weeks
Title
Physical activity
Description
Telemetric sensor
Time Frame
4 weeks
Title
Body weight (kg)
Description
Bio-impedance analysis (SECA)
Time Frame
4 weeks
Title
Total body water (L)
Description
Bio-impedance analysis (SECA)
Time Frame
4 weeks
Title
Extracellular water (L)
Description
Bio-impedance analysis (SECA)
Time Frame
4 weeks
Title
Skeletal muscle mass (kg)
Description
Bio-impedance analysis (SECA)
Time Frame
4 weeks
Title
Fat-free mass (kg)
Description
Bio-impedance analysis (SECA)
Time Frame
4 weeks
Title
Fat mass (kg)
Description
Bio-impedance analysis (SECA)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian L Hvas, PhD
Phone
+4528351839
Email
christian.hvas@auh.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Rud, MSc
Phone
+4578453800
Email
charru@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian L Hvas, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian L Hvas, MD PhD
Phone
+45 28351839
Email
christian.hvas@auh.rm.dk
First Name & Middle Initial & Last Name & Degree
Charlotte Rud, MS
Email
charru@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
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