Short Bowel Syndrome Clinical Trial
— ABSOLYTOfficial title:
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy
Verified date | March 2024 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
Christian Hvas |
Denmark,
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 |
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