Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 1:17 PM
Study NCT ID:
NCT07201428
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fiber-Enriched Enteral Nutrition and Opioid-Induced Constipation in the ICU
Sponsor:
Sisli Hamidiye Etfal Training and Research Hospital
Organization:
Study Overview
Official Title:
The Effects of Fiber Content in Enteral Nutrition Products on Opioid-Induced Constipation in Intubated Patients
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief Summary:
Opioid use for sedation and analgesia is widespread among mechanically ventilated ICU patients, often leading to gastrointestinal dysfunction and opioid-induced constipation (OIC). While enteral nutrition (EN) is routinely used in critical care, the role of fiber-enriched EN formulas in preventing OIC remains unclear. This prospective quasi-randomized study aims to evaluate whether fiber-containing EN products reduce the incidence and severity of OIC compared to fiber-free formulations in intubated ICU patients. The findings may contribute to optimizing nutritional strategies to mitigate constipation-related complications in this high-risk population.
Detailed Description:
The use of opioids for sedation and analgesia is common among intensive care unit (ICU) patients requiring mechanical ventilation. However, frequent and sometimes high-dose opioid administration can lead to gastrointestinal dysfunction and complications such as constipation. These complications are associated with increased risk of gastric content aspiration, suboptimal nutritional intake, prolonged ICU stays, and higher mortality rates.
Enteral nutrition (EN) is routinely administered to ICU patients unless there is a contraindication to gastrointestinal feeding . EN products are formulated with diverse compositions to address the needs of ICU patients, who represent a highly heterogeneous population. High-fiber EN formulations are typically used in patients with diarrhea or constipation. However, current literature lacks evidence regarding the efficacy of fiber-enriched EN in reducing constipation among intubated ICU patients.
In the study, the investigator aim to investigate whether high-fiber EN products have an effect on opioid-induced constipation compared to fiber-free products in intubated patients.
Enteral nutrition (EN) is routinely administered to ICU patients unless there is a contraindication to gastrointestinal feeding . EN products are formulated with diverse compositions to address the needs of ICU patients, who represent a highly heterogeneous population. High-fiber EN formulations are typically used in patients with diarrhea or constipation. However, current literature lacks evidence regarding the efficacy of fiber-enriched EN in reducing constipation among intubated ICU patients.
In the study, the investigator aim to investigate whether high-fiber EN products have an effect on opioid-induced constipation compared to fiber-free products in intubated patients.
Study Oversight
Has Oversight DMC:
None
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?: