Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 12:27 PM
Study NCT ID:
NCT04555434
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2020-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D002482', 'term': 'Cellulose'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Evaluates the effect of probiotic improvement on non-alcoholic fatty liver disease in patients diagnosed with non-alcoholic fatty liver disease.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic characteristics', 'timeFrame': '1 week', 'description': 'The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY'}, {'measure': 'Primary Outcomes; Liver Function Test', 'timeFrame': 'Baseline of AST, ALT, rGT, CHOL, and ALP at first week.', 'description': 'Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)\\[IU/L\\]'}, {'measure': 'Gut-Microbiome Composition', 'timeFrame': 'Change from Baseline of fecal microbiome at 8 months', 'description': 'Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio'}, {'measure': 'Computed Tomography', 'timeFrame': 'Change from Baseline of CT image at 8 months', 'description': 'change of the Abdominal ultrasonography or Computed Tomography(CT): Upper abdominal ultrasound or CT to determine the degree of fatty liver disease\n\n② Fibroscan: Objectively and quantitatively grasp the degree of liver fibrosis by measuring the degree of firmness (elasticity) of the liver'}, {'measure': 'change of BMI', 'timeFrame': 'Change from Baseline BMI and weight at 6 months', 'description': 'Compare the body mass index. BMI=Body Weight/(Height)\\^2'}, {'measure': 'Secondary Outcomes; Liver Function Test', 'timeFrame': 'Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months', 'description': 'Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)\\[IU/L\\]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Liver disease', 'Gut microbiota'], 'conditions': ['Non-Alcoholic Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '41366779', 'type': 'DERIVED', 'citation': 'Won SM, Joung H, Park IG, Han SH, Ham YL, Han JS, Kwon Y, Kim DJ, Suk KT. The effects of next generation probiotics on metabolic dysfunction-associated steatotic liver disease: a parallel, double-blind, randomized, placebo-controlled trial. J Transl Med. 2025 Dec 9. doi: 10.1186/s12967-025-07478-z. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'A study for evaluating the improvement effect of non-alcoholic steatohepatitis (NASH) of probiotics', 'detailedDescription': 'Non-alcoholic fatty liver disease progresses to fatty liver, hepatitis, cirrhosis, and liver cancer, resulting in a high mortality rate. The prevalence of non-alcoholic fatty liver disease at home and abroad is a major social and economic burden. However, there is no cure for non-alcoholic fatty liver disease. Recently, intestinal axis theory related to the development of chronic liver disease and microbial community has emerged. Intake of probiotics is known to play a role in regulating gut microflora. Improvement of non-alcoholic fatty liver disease can be expected through administration of probiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Those who agreed to participate in this study and signed a written consent\n2. Adult men and women over 20\n3. Patients diagnosed with non-alcoholic fatty liver\n\n ※ Exclusion criteria for alcoholic liver disease\n * Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)\n * 1 bottle of shochu 360 ml \\* 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) \\* 5% = 25 (16.5 g)\n4. Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme\n\n * AST, ALT: 40 or less\n * ALP: 20-130\n * GOT: 0-30, GPT: 0-38\n * GGT: 10-62 (male), 7-35 (female)\n\nExclusion Criteria:\n\n1. Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.\n2. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period\n3. Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.\n4. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)\n5. If you have any of the following\n\n * Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis\n * systemic inflammatory disease or immune disease\n * Hepatocellular carcinoma\n * Uncontrolled cardiopulmonary disease\n * Other serious systemic disorders in the heart, lungs, blood, and endocrine system\n6. A person with a history of malignancy diagnosis within the last 5 years\n7. Pregnant or lactating women\n8. Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions\n9. Those who are not suitable for the clinical trial because the investigator judges'}, 'identificationModule': {'nctId': 'NCT04555434', 'briefTitle': 'Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in Patients With Nonalcoholic Hepatitis', 'orgStudyIdInfo': {'id': 'PRO-NASH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics group', 'description': 'The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations.', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations.', 'interventionNames': ['Dietary Supplement: Probiotics']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cellulose (Placebo)'], 'description': '* Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10\\^9 CFU / day)\n* Control group Main ingredient: Crystalline cellulose', 'armGroupLabels': ['Placebo group', 'Probiotics group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-704', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki Tae Suk', 'role': 'CONTACT', 'phone': '+82-10-5365-5700'}], 'facility': 'Hallym University Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'centralContacts': [{'name': 'Ki Tae Suk, Professor', 'role': 'CONTACT', 'email': 'ktsuk@hallym.ac.kr', 'phone': '+82-10-5365-5700'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}