Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:14 AM
Study NCT ID:
NCT07422792
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-group study assessing anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure receiving home parenteral nutrition.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion', 'timeFrame': 'Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day)', 'description': 'Protein anabolic response will be assessed by whole-body protein kinetics using a stable isotope tracer methodology during intravenous amino acid administration. The outcome will be reported as the change in whole-body protein synthesis rate (µmol/kg/h) from baseline to post-infusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parenteral Nutrition', 'Intravenous Amino Acids'], 'conditions': ['Chronic Intestinal Failure', 'Intestinal Failure', 'Home Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Based on collected data on protein kinetics, the study aims to further refine and personalize nutritional mixtures in patients with CIF. Additional aims include assessment of short-chain fatty acid metabolism and evaluation of gut microbiota function in patients with CIF.', 'detailedDescription': 'This prospective cohort study evaluates anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure (CIF) receiving home parenteral nutrition. The study aims to improve therapy of CIF patients by providing new insights into metabolism and anabolic response. Protein kinetics will be assessed to better define protein requirements and to support optimization and personalization of parenteral nutrition mixtures. The study will also assess short-chain fatty acid metabolism and provide insight into gut microbiota function in CIF patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.'}, 'identificationModule': {'nctId': 'NCT07422792', 'briefTitle': 'Anabolic Response To Intravenous Amino Acids In Chronic Intestinal Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Anabolic Response To Protein And Assessment Of Metabolic Phenotype In Patients With Home Parenteral Nutrition And Chronic Intestinal Failure', 'orgStudyIdInfo': {'id': 'OI-707-CIF-2022'}, 'secondaryIdInfos': [{'id': '0120-131/2022/6', 'type': 'OTHER', 'domain': 'National Medical Ethics Committee of the Republic of Slovenia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous Amino Acid Administration', 'description': 'Patients with chronic intestinal failure receiving home parenteral nutrition receive intravenous amino acid administration for assessment of anabolic response and metabolic phenotype.', 'interventionNames': ['Drug: Intravenous Amino Acids']}], 'interventions': [{'name': 'Intravenous Amino Acids', 'type': 'DRUG', 'description': 'Intravenous amino acid administration to assess anabolic response and protein kinetics in patients with chronic intestinal failure receiving home parenteral nutrition', 'armGroupLabels': ['Intravenous Amino Acid Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Klavdija Korošec', 'role': 'CONTACT', 'email': 'kkorosec@onko-i.si', 'phone': '+386 31630065'}, {'name': 'Neža Gros', 'role': 'CONTACT', 'email': 'ngros@onko-i.si'}], 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Klavdija Korošec', 'role': 'CONTACT', 'email': 'kkorosec@onko-i.si', 'phone': '+386 31630065'}, {'name': 'Neža Gros', 'role': 'CONTACT', 'email': 'ngros@onko-i.si'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}