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Completed

NCT Number: NCT04141826

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrolysed whey

Dietary Supplement

500 mL solution of 25 gram hydrolysed whey per day during 4 weeks

Intact whey

Dietary Supplement

500 mL solution of 25 gram intact whey per day during 4 weeks

Caseinate

Dietary Supplement

500 mL solution of 25 gram casein ate per day during 4 weeks

Primary outcomes

  1. 24-hour fecal wet weight

    Time frame: 4 weeks

    Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period

Secondary outcomes

  1. Diuresis

    Time frame: 4 weeks

    24 hour urine volume

  2. Natriuresis

    Time frame: 4 weeks

    24 hour urine sodium excretion

  3. Amino acid absorption

    Time frame: 6 hours

    Plasma amino acids

  4. Gastric and small bowel emptying

    Time frame: 6 hours

    3D transit evaluation

  5. GLP1 and GLP2

    Time frame: 6 hours

    Intestinal hormones during absorption

  6. Portosystemic hepatic encephalopathy (PSE) test score, median value

    Time frame: 4 weeks

    Pen and paper test, score with range

  7. Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4)

    Time frame: 4 weeks

    Pen and paper test, score with range

  8. Continuous reaction time (CRT) index median

    Time frame: 4 weeks

    Reaction to 150 sound stimuli, read-out as index compared to normal values

  9. Physical activity

    Time frame: 4 weeks

    Telemetric sensor

  10. Body weight (kg)

    Time frame: 4 weeks

    Bio-impedance analysis (SECA)

  11. Total body water (L)

    Time frame: 4 weeks

    Bio-impedance analysis (SECA)

  12. Extracellular water (L)

    Time frame: 4 weeks

    Bio-impedance analysis (SECA)

  13. Skeletal muscle mass (kg)

    Time frame: 4 weeks

    Bio-impedance analysis (SECA)

  14. Fat-free mass (kg)

    Time frame: 4 weeks

    Bio-impedance analysis (SECA)

  15. Fat mass (kg)

    Time frame: 4 weeks

    Bio-impedance analysis (SECA)

Sponsors and collaborators

Lead sponsor

Christian Hvas

Other

Registry information

Acronym: ABSOLYT

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 28, 2019
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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