Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT07166458
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2025-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kefir Peptides for Bone Fracture Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants and care providers are blinded to treatment assignment. The kefir peptide supplement and placebo are identical in appearance and packaging.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to two parallel groups: one group receiving kefir peptide supplementation plus standard care, and the other group receiving standard care alone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-09-02', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic Healing Score at 3 Months', 'timeFrame': '3 months after fracture fixation', 'description': 'Bone healing will be assessed using standard radiographs and the modified Lane and Sandhu scoring system.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Fractures']}, 'referencesModule': {'references': [{'pmid': '40192921', 'type': 'BACKGROUND', 'citation': 'Lai JC, Chang GR, Tu MY, Cidem A, Chen IC, Chen CM. Potential of Kefir-Derived Peptides, Probiotics, and Exopolysaccharides for Osteoporosis Management. Curr Osteoporos Rep. 2025 Apr 7;23(1):18. doi: 10.1007/s11914-025-00910-9.'}, {'pmid': '36257457', 'type': 'BACKGROUND', 'citation': 'Lai JC, Li HP, Chang GR, Lan YW, Chen YH, Tseng YS, Tu MY, Chen CF, Chen HL, Chen CM. Kefir peptides promote osteogenic differentiation to enhance bone fracture healing in rats. Life Sci. 2022 Dec 1;310:121090. doi: 10.1016/j.lfs.2022.121090. Epub 2022 Oct 17.'}], 'seeAlsoLinks': [{'url': 'https://www.nchu.edu.tw', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effects of kefir-derived peptides on bone healing in patients with upper limb fractures. Kefir peptides are natural protein fragments that may promote bone formation and reduce inflammation. Participants with recent upper limb fractures will be randomly assigned to receive either kefir peptide supplementation or standard treatment. The main purpose of this study is to determine whether kefir peptides can accelerate bone healing and improve recovery compared to standard care.', 'detailedDescription': 'This study aims to investigate the efficacy of kefir-derived peptides in enhancing bone healing after upper limb fractures. Kefir peptides are bioactive fragments of milk proteins that have shown potential in stimulating osteoblast differentiation, inhibiting osteoclast activity, and modulating inflammation in preclinical studies.\n\nThe study is designed as a randomized, controlled clinical trial. Eligible participants with acute upper limb fractures will be randomly assigned to receive either kefir peptide supplementation in addition to standard care, or standard care alone. The primary objective is to evaluate radiographic and clinical healing at 6 months, while secondary outcomes include pain relief, functional recovery, and quality of life measures.\n\nThis trial seeks to provide clinical evidence supporting kefir peptides as a safe and natural adjunct therapy to accelerate bone repair, potentially reducing recovery time and improving functional outcomes for patients with fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) patients with a bone mineral density T-score determined by dual energy X-ray absorptiometry (DXA) \\< -2.5 or patients with acute fragile fractures in the distal radius and proximal humerus, and additionally (2) women with menopause or (3) patients who are over 50 years of age.\n\nExclusion Criteria:\n\n* (1) a body mass index (BMI) \\> 30, (2) those who have been administered pharmacological agents such as glucocorticoids, thyroxine, antiepileptics, bisphosphonates, calcitonin, and hormone replacement therapy, or medications impacting bone metabolism for a duration over 4 months, and (3) individuals with a documented medical history of hyperparathyroidism, hyperthyroidism, diabetes mellitus, hepatic cirrhosis, and renal insufficiency'}, 'identificationModule': {'nctId': 'NCT07166458', 'acronym': 'KPs-Fracture', 'briefTitle': 'Kefir Peptides for Bone Fracture Healing', 'organization': {'class': 'OTHER', 'fullName': 'National Chung Hsing University'}, 'officialTitle': 'Fuctional Assessment of Kefir Fermented Milk on the Improvement of Osteoporosis Combined With Fracture Patient', 'orgStudyIdInfo': {'id': 'B202005023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kefir Peptide + Standard Care', 'description': 'Participants will receive kefir peptide supplementation in addition to standard fracture care.', 'interventionNames': ['Dietary Supplement: Kefir Peptide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Participants will receive standard fracture care without kefir peptide supplementation.', 'interventionNames': ['Other: Standard Care (in control arm)']}], 'interventions': [{'name': 'Kefir Peptide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral supplementation with kefir-derived bioactive peptides given daily in addition to standard care.', 'armGroupLabels': ['Kefir Peptide + Standard Care']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': 'Standard fracture management including immobilization, pain control, and routine follow-up care.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'National Chung Hsing University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jen-Chieh Lai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Taichung Armed Forces General Hospital', 'investigatorFullName': 'Jen-Chieh Lai', 'investigatorAffiliation': 'National Chung Hsing University'}}}}