Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-05 @ 2:33 AM
Study NCT ID:
NCT07010068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-12', 'size': 791150, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-31T03:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open-label, randomized, multicentric, interventional TGF-β2-enriched supplementation (Modulen IBD ®) in patients submitted to allogeneic hematopoietic stem cell transplantation (allo-HSCT)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 214}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention', 'timeFrame': 'given from day -7 to day +28', 'description': '● PG-SGA score C (severe malnutrition) at day +28 \\<50%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stem Cell Transplant', 'malnutrution', 'gvhd'], 'conditions': ['Malnutrition (Calorie)', 'Stem Cell Transplant Complications']}, 'descriptionModule': {'briefSummary': 'prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intact intestinal tract\n* Life expectancy more than 12 weeks\n* Allogeneic stem cell transplantation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active hematological disease at the beginning of conditioning\n* Personal history of inflammatory bowel diseases\n* Personal history of bowel resection\n* Personal history of gastric bypass procedures\n* Enrolment in a competitive prospective study (malnutrition or GVHD as primary outcome)\n* Subjects with known hypersensitivity to milk proteins or components of Modulen-IBD'}, 'identificationModule': {'nctId': 'NCT07010068', 'acronym': 'TGF-Nutri', 'briefTitle': 'Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}, 'officialTitle': 'Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study - (TGF-NUTRIALLO Study)', 'orgStudyIdInfo': {'id': 'NP 6412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MODULEN-IBD SUPPLEMENTATION', 'description': "From hospital admission to day +28 calories by Modulen-IBD® will integrate oral diet with 20% of calories by Modulen IBD® of TDEE, according to table 2 and to twice weekly monitoring\n\nOral administration:\n\nOnce reconstituted with bottled water according label instructions and at a caloric concentration of ≤1 kcal/ml, the supplement could be flavored according to the patient's tastes with barley coffee or decaffeinated coffee or cocoa. It is recommended to take in 2-3 portions to be taken throughout the day.\n\nNGT route:\n\nPlacement of a small NGT (max 8-10 fr.) is recommended. Food assumption is encouraged even when NGT is placed. In case of NGT placement, the amount of calories by tube is the difference between TDEE and the amount of calories assumed with food.\n\nModulen IBD® will be prepared and administered in 100-250 ml boluses (every 4-6 hours) to ensure the stability of the product.\n\nIf a patient refuses food, Enteral Nutrition as polymeric standard, isocaloric, isoproteic, +/- fibers,", 'interventionNames': ['Dietary Supplement: TGF-β2-enriched food for special medical purposes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BST (Best Supportive Treatment)', 'description': "Nutritional support in patients randomized to BST should be carried out according to EBMT-Handbook standards. If the patient's caloric intake is less than 75% for 3 days (instead 60% as proposed by EBMT manual) nutritional intervention is warranted and calculated according to BMI (see above).\n\nONS: ONS should ensure the same amount of caloric intake of the experimental treatment in addition to usual food assumption. If patients could not assume the right amount of calories with ONS and refuse NGT parenteral nutrition is permitted.\n\nParenteral Nutrition (PN): 3-1 formulations with a 1.1 Kal/ml content should be preferred (ex. Smofkabiven®, Olimel®) through a central line. The choice of PN type is according to the center's policy and used in combination with food or ONS assumption.", 'interventionNames': ['Dietary Supplement: BST']}], 'interventions': [{'name': 'TGF-β2-enriched food for special medical purposes', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental treatment is Modulen-IBD®, a food for special medical purpose, polymeric, enriched with TGF-beta. If the patient refuses the experimental supplementation, NGT will be proposed to ensure the correct intake of Modulen-IBD® supplementation.\n\nIf the patient refuses, not tolerates, or there are contraindications to NGT placement, best supportive therapy will be warranted as reported below (BST).', 'armGroupLabels': ['MODULEN-IBD SUPPLEMENTATION']}, {'name': 'BST', 'type': 'DIETARY_SUPPLEMENT', 'description': "Best Nutritional Supportive Treatment as per center's policy according to EBMT Handbook 2024", 'armGroupLabels': ['BST (Best Supportive Treatment)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Enrico Morello, MD, PhD', 'role': 'CONTACT', 'email': 'enrico.morello@asst-spedalicivili.it', 'phone': '0303996811', 'phoneExt': '+39'}, {'name': 'Alessandro Leoni, MSC', 'role': 'CONTACT', 'email': 'alessandro.leoni@unibs.it', 'phone': '0303998467', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Enrico Morello, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asst Degli Spedali Civili Di Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Enrico Morello, Principal Investigator, Head of Supportive Care Unit', 'investigatorFullName': 'Enrico Morello', 'investigatorAffiliation': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia'}}}}