Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-26 @ 4:50 AM
Study NCT ID:
NCT07231666
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2022-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Goldilocks' Zone: Optimised Osmolality in Supplements for the Patient With an Ileostomy
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Goldilocks
Brief Summary:
Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy
Detailed Description:
14 patients with ileostomies were included in a quasi-randomized, crossover intervention study. Each patient ingested between 3-18 different supplements during separate 6-hours intervention periods. Ileostomy output and urine volume will be collected. Outcome measures include faecal wet-weight, urine volume, electrolytes, osmolality, and body composition measured with bioelectrical impedance analysis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: