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

September 23, 2025 updated by: Olcay Dilken, Sisli Hamidiye Etfal Training and Research Hospital

The Effects of Fiber Content in Enteral Nutrition Products on Opioid-Induced Constipation in Intubated Patients

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34371
        • Sisli Hamidiye Etfal Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the day of first defecation
Time Frame: 1-7 days
The definition of first defecation was defined as stool volume >100 ml
1-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for enema use
Time Frame: 1-7 days
Indication for constipation and need for enema use
1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

September 23, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • olcay-31

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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