Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
Study NCT ID:
NCT03940768
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2019-01-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of fat mass', 'timeFrame': 'at baseline and after 4th week', 'description': 'fat mass in percent (%)'}, {'measure': 'Changes of muscle mass', 'timeFrame': 'at baseline and after 4th week', 'description': 'muscle mass in kilograms (kg)'}, {'measure': 'Changes of total body water', 'timeFrame': 'at baseline and after 4th week', 'description': 'total body water in percent (%)'}, {'measure': 'Changes of body mass index', 'timeFrame': 'at baseline and after 4th week', 'description': 'body mass index in kg/m\\^2'}, {'measure': 'Changes of the albumin concentration', 'timeFrame': 'at baseline and after 4th week', 'description': 'albumin concentration g/L'}, {'measure': 'Changes of total protein concentration', 'timeFrame': 'at baseline and after 4th week', 'description': 'total protein concentration g/L'}, {'measure': 'Changes of total lymphocyte count', 'timeFrame': 'at baseline and after 4th week', 'description': 'number of total lymphocyte count/mm\\^3'}], 'secondaryOutcomes': [{'measure': 'Change of enteral nutrition tolerance', 'timeFrame': 'it will be filled every day by patients per 4 weeks treatment period', 'description': 'The enteral nutrition tolerance will be assessed with authors own questionnaire referring to number of stools, frequency of vomiting and flatulence.'}, {'measure': "Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life)", 'timeFrame': 'at baseline and after 4th week', 'description': 'Questionare containing questions divided in 4 domains (regarding environment, psychological, somatic, social factors). Each question gets points in scale 1-5, where 1 being the worst score. Within each domain poins are summed up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'home enteral nutrition', 'probiotic', 'Lactobacillus plantarum 299v'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '32917221', 'type': 'DERIVED', 'citation': 'Kazmierczak-Siedlecka K, Folwarski M, Skonieczna-Zydecka K, Ruszkowski J, Makarewicz W. The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial. Nutr J. 2020 Sep 11;19(1):98. doi: 10.1186/s12937-020-00598-w.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the impact of Lactobacillus plantarum 299v on nutritional status, tolerance of enteral diet and the quality of life. Administration of this probiotic may potentially improve nutritional status and tolerance of enteral diet. It also may provide positive effect on quality of life.', 'detailedDescription': 'Study group consists of patients with cancer who are qualified for home enteral nutrition in Nutritional Counselling Center Copernicus in Gdansk. The control group will receive home enteral nutrition and placebo. The experimental group will receive home enteral nutrition and Lactobacillus plantarum 299v. The study is prospective and double-blind. The parameters for evaluation of nutritional status are: BMI, body mass analysis, level of total protein and albumin in blood serum, total lymphocyte count, NRS 2002 method. Assessment of the quality of life and tolerance of enteral diet will be done by questionaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 yr.,\n* the presence of cancer, artificial access to the alimentary tract (naso-gastric tube, gastrostomy, percutaneous endoscopic gastrostomy, jejunostomy, microjejunostomy),\n* qualification for home enteral nutrition,\n* written consent to take part in the study\n\nExclusion Criteria:\n\n* age \\<18 yr.,\n* patients requiring home parenteral nutrition,\n* patients who are not being able to attend the visit in the study centre.'}, 'identificationModule': {'nctId': 'NCT03940768', 'briefTitle': 'The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition', 'orgStudyIdInfo': {'id': 'MUGdansk1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus plantarum 299v receivers', 'description': 'Sanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum 299v', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo receivers', 'description': 'Sanprobi IBS placebo 2 capsules per day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum 299v', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum 299v', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition.', 'armGroupLabels': ['Lactobacillus plantarum 299v receivers', 'Placebo receivers']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of placebo in cancer patients who receive home enteral nutrition.', 'armGroupLabels': ['Lactobacillus plantarum 299v receivers', 'Placebo receivers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gdansk', 'country': 'Poland', 'facility': 'Nutritional Counselling Centre Copernicus in Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Karolina Kaźmierczak-Siedlecka (nutritionist, PhD student - Department of Surgical Oncology)', 'investigatorFullName': 'Karolina Kaźmierczak-Siedlecka', 'investigatorAffiliation': 'Medical University of Gdansk'}}}}