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Completed

NCT Number: NCT07201428

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the day of first defecation

    Time frame: 1-7 days

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

Secondary outcomes

  1. Need for enema use

    Time frame: 1-7 days

    Indication for constipation and need for enema use

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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