Fiber-Enriched Enteral Nutrition and Opioid-Induced Constipation in the ICU

NCT07201428 | Completed

• 1 other identifier: olcay-31
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation, Opioid-Induced

Keywords

constipation; opioid; mechanical ventilation; sedation

Outcome Measures

Primary Outcomes (1)

• the day of first defecation

  The definition of first defecation was defined as stool volume \>100 ml

  1-7 days

Secondary Outcomes (1)

• Need for enema use

  1-7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients over the age of 18 who are initiated on enteral nutrition and are on mechanical ventilation will be included in the study

You may qualify if:

• All patients over the age of 18 who are initiated on enteral nutrition and are on mechanical ventilation will be included in the study.

You may not qualify if:

• Pediatric and pregnant patients
• Life expectancy less than 24 hours
• Gastrointestinal surgery within the last week
• Intra-abdominal pressure \> 15 mmHg
• Shock requiring high vasopressor support
• Contraindication to enteral nutrition
• Intubation \>48 hours

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: December 20, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

TU (1)