Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 1:17 PM
Study NCT ID:
NCT07201428
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fiber-Enriched Enteral Nutrition and Opioid-Induced Constipation in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '7 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the day of first defecation', 'timeFrame': '1-7 days', 'description': 'The definition of first defecation was defined as stool volume \\>100 ml'}], 'secondaryOutcomes': [{'measure': 'Need for enema use', 'timeFrame': '1-7 days', 'description': 'Indication for constipation and need for enema use'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['constipation', 'opioid', 'mechanical ventilation', 'sedation'], 'conditions': ['Constipation, Opioid-Induced']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEnteral 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients over the age of 18 who are initiated on enteral nutrition and are on mechanical ventilation will be included in the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over the age of 18 who are initiated on enteral nutrition and are on mechanical ventilation will be included in the study.\n\nExclusion Criteria:\n\n* Pediatric and pregnant patients\n* Life expectancy less than 24 hours\n* Gastrointestinal surgery within the last week\n* Intra-abdominal pressure \\> 15 mmHg\n* Shock requiring high vasopressor support\n* Contraindication to enteral nutrition\n* Intubation \\>48 hours'}, 'identificationModule': {'nctId': 'NCT07201428', 'briefTitle': 'Fiber-Enriched Enteral Nutrition and Opioid-Induced Constipation in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'The Effects of Fiber Content in Enteral Nutrition Products on Opioid-Induced Constipation in Intubated Patients', 'orgStudyIdInfo': {'id': 'olcay-31'}}, 'contactsLocationsModule': {'locations': [{'zip': '34371', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sisli Hamidiye Etfal Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Olcay Dilken', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}