Constipation, Opioid-InducedNCT07201428
Fiber-Enriched Enteral Nutrition and Opioid-Induced Constipation in the ICU
An observational study of Constipation, Opioid-Induced, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Opioid-Induced
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 30 Aug 2025
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- All patients over the age of 18 who are initiated on enteral nutrition and are on mechanical ventilation will be included in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training Hospital
Istanbul, 34371
About this study
Official title: 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.
Read the 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.
- Conditions
- Constipation, Opioid-Induced
- Keywords
- constipation, opioid, mechanical ventilation, sedation
- Medical subject headings
- Opioid-Induced Constipation, Constipation
What is being measured
The primary outcome is the main question the study is designed to answer.
the day of first defecation
The definition of first defecation was defined as stool volume >100 ml
Measured: 1-7 days
Secondary outcomes (1)
Need for enema use
Indication for constipation and need for enema use
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start20 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation, Opioid-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olcay Dilken, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201428
- Sponsor's protocol ID
- olcay-31
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fiber Content in Enteral Nutrition Products on Opioid-Induced Constipation in Intubated Patients
- ClinicalTrials.gov ID
- NCT07201428
- Acronym / sponsor ID
- olcay-31
- Conditions
- Constipation, Opioid-Induced
- Keywords
- constipation, opioid, mechanical ventilation, sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients over the age of 18 who are initiated on enteral nutrition and are on mechanical ventilation will be included in the study.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the day of first defecation
Time frame: 1-7 days
The definition of first defecation was defined as stool volume >100 ml
1 secondary outcome
Need for enema use
Time frame: 1-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, Opioid-Induced, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the day of first defecation (time frame: 1-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.