NCT07201428

Completed

Fiber-Enriched Enteral Nutrition and Opioid-Induced Constipa...

Sisli Hamidiye Etfal Training and Research Hospital Source

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Other study identifiers

Sponsor study identifier

olcay-31

Study Type

observational

Actual enrollment (reported)

80

Locations

1 country

Sites

1

Timeline

Study Start

December 20, 2024

Actual (reported)

Primary Completion

July 30, 2025

Actual (reported)

Study Completion

August 30, 2025

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 80 participants
Study completion date: August 30, 2025
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 20, 2024
Actual (reported)
Primary Completion
July 30, 2025
Actual (reported)
Study Completion
August 30, 2025
Actual (reported)
First Submitted
September 23, 2025
Actual (reported)
First Posted
October 1, 2025
Actual (reported)

Last Updated: October 1, 2025
Status Verified: September 2025
Last Update Submitted: September 23, 2025

Conditions

Constipation, Opioid-Induced

Keywords

constipationopioidmechanical ventilationsedation

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

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

Sponsors & Collaborators

Sisli Hamidiye Etfal Training and Research Hospital
Otherlead

Study Sites (1)

Sisli Hamidiye Etfal Training Hospital

Istanbul, 34371, Turkey (Türkiye)

MeSH Terms

Conditions

Opioid-Induced ConstipationConstipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Enrollment

80 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT01382797

ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Phase 2Completed

NCT01965158

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

Phase 3Completed

NCT01993940

Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

Phase 3Completed

NCT01957046

A Single-arm, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy (SLT) for the Reversal of Opioid-induced Constipation (OIC).

Phase 4Completed

NCT01207427

Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain

Phase 2Completed

NCT01384292

Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

Phase 3Terminated

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

Contact the study team to confirm eligibility.

Primary Completion

July 30, 2025

Actual (reported)

Study Completion

August 30, 2025

Actual (reported)

Last Updated

October 1, 2025

Record last verified: 2025-09

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT07201428
Data provider: ClinicalTrials.gov
Source updated: 2025-10-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:03 UTC

Locations

TR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations