NCT04141826

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Christian Hvas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydrolysed whey	500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
DIETARY_SUPPLEMENT	Intact whey	500 mL solution of 25 gram intact whey per day during 4 weeks
DIETARY_SUPPLEMENT	Caseinate	500 mL solution of 25 gram casein ate per day during 4 weeks

Timeline

• Start date: 2020-01-27
• Primary completion: 2022-11-01
• Completion: 2023-07-13
• First posted: 2019-10-28
• Last updated: 2024-03-04

Locations

1 site across 1 country: Denmark