Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-26 @ 11:54 PM
Study NCT ID:
NCT06502834
Status:
RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The pharmacist will provide the study intervention to the investigator in a coded fashion. Both the investigator and the participant are blinded.\n\nIn case of emergency, an unblinding protocol is activated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2x10 participants will be randomly allocated to placebo or d piger suspension once daily.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut engraftment', 'timeFrame': '30 days', 'description': 'the number of reads of d piger in feces using q pcr'}, {'measure': 'adverse events', 'timeFrame': '30 days', 'description': 'the number of adverse events in both groups'}, {'measure': 'Renal function', 'timeFrame': '30 days', 'description': 'Number of participants with a decreased kidney function, defined as a rise in serum creatinine of \\>26,5 micromol/L in 48 h'}, {'measure': 'Occurence of anemia', 'timeFrame': '30 days', 'description': 'Number of patients with Hb \\< 8,5 mmol/L'}, {'measure': 'Changes in leucocytes', 'timeFrame': '30 days', 'description': 'Number of patients with leucocytes \\<4,0 or \\>10,5 x10E9 cells/L'}, {'measure': 'Changes in thrombocytes', 'timeFrame': '30 days', 'description': 'Number of patients with thrombocytes \\<150 x 10E9 cells/'}, {'measure': 'Changes in aspartate aminotransferase (AST)', 'timeFrame': '30 days', 'description': 'Number of patients with AST \\> 43 IU/L'}, {'measure': 'Changes in alanine aminotransferase (ALT)', 'timeFrame': '30 days', 'description': 'Number of patients with ALT \\> 45 IU/L'}, {'measure': 'Changes in alkaline phosphatase (ALP)', 'timeFrame': '30 days', 'description': 'Number of patients with ALP \\> 126 IU/L'}, {'measure': 'Changes in Gamma-glutamyltransferase (GGT)', 'timeFrame': '30 days', 'description': 'Number of patients with GGT \\> 117 IU/L'}, {'measure': 'Changes in total bilirubin', 'timeFrame': '30 days', 'description': 'Number of patients with total bilirubin \\> 24 micromol/L'}], 'secondaryOutcomes': [{'measure': 'Fructose in peripheral blood', 'timeFrame': '30 days', 'description': 'Area under the curve of fructose in peripheral blood upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6'}, {'measure': 'Fructose metabolites in breath', 'timeFrame': '30 days', 'description': 'Area under the curve of various metabolites (e.g. ethanol) will be measured in breath samples upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6'}, {'measure': 'Time-in-range', 'timeFrame': '30 days', 'description': 'Increase in Time-in-range (TIR,%), a parameter of continuous glucose monitoring devices, where TIR can be between 0 and 100%. A higher TIR reflects a better outcome.'}, {'measure': 'Continuous glucose monitoring', 'timeFrame': '30 days', 'description': 'Decrease in glucose variability (GV, %), a parameter of continuous glucose monitoring devices, where GV can be between 0 and 100%. A lower GV reflects a better outcome.'}, {'measure': 'Glycemic control', 'timeFrame': '30 days', 'description': 'Changes in fasting glucose (mmol/L)'}, {'measure': 'Dietary intake', 'timeFrame': '30 days', 'description': 'Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visit 2,3,4,5 and 7'}, {'measure': 'Questionnaires', 'timeFrame': '30 days', 'description': 'Changes in Gastro-intestinal Quality of Life Index (GIQLI score) (points). The minimum and maximum score are 31 and 155 points respectively, and a higher score reflects a better outcome.'}, {'measure': 'Intestinal microbiota composition', 'timeFrame': '30 days', 'description': 'Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.'}, {'measure': 'Fructose metabolites in feces', 'timeFrame': '30 days', 'description': 'Using 24h feces, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as short chain fatty acids (SCFAs) and bile acids.'}, {'measure': 'Fructose metabolites in urine', 'timeFrame': '30 days', 'description': 'Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.'}, {'measure': 'Bioreactor analyses', 'timeFrame': '30 days', 'description': 'Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.'}, {'measure': 'MRI', 'timeFrame': '30 days', 'description': 'Liver fat measured by proton density fat fraction (PDFF) MRI liver'}, {'measure': 'FibroScan', 'timeFrame': '30 days', 'description': 'Liver stiffness measured by FibroScan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Syndrome', 'Steatosis of Liver']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.\n\nThe investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.', 'detailedDescription': 'The investigators perform a randomized, placebo controlled trial in 2x10 participants.\n\nThe participants will be given placebo or d piger as an oral suspension once daily for 30 days.\n\nAt baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and MRI liver + FibroScan will be performed. Patient will attend the clinical trial unit weekly for safety visits.\n\nThe participants will be overweight males or females age 18-70 with impaired glucose tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\nMale or (postmenopausal) females\n\n* Increased waist circumference (\\>102 cm men, 88\\>cm women)\n* Insulin resistance (HOMA\\>2.5)\n* 18-70 years\n\nExclusion Criteria:\n\n* Use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period.\n* A history of a cardiovascular event\n* A history of cholecystectomy\n* Overt untreated gastrointestinal disease or abnormal bowel habits\n* Liver enzymes\\>2.5 fold higher than the upper limit of normal range\n* Smoking\n* Alcohol abuse'}, 'identificationModule': {'nctId': 'NCT06502834', 'acronym': 'PIGER', 'briefTitle': 'Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)', 'orgStudyIdInfo': {'id': '2023.0787'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo vial (10ml of glycerol 10% and 10% maltrodextrin)', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'D piger', 'description': 'D. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin).', 'interventionNames': ['Dietary Supplement: D piger']}], 'interventions': [{'name': 'D piger', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic d piger', 'armGroupLabels': ['D piger']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'max nieuwdorp, MD PhD', 'role': 'CONTACT', 'email': 'm.nieuwdorp@amsterdamumc.nl', 'phone': '0031 20 5669111'}], 'facility': 'Amsterdam UMC location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'M Nieuwdorp, prof dr', 'role': 'CONTACT', 'email': 'm.nieuwdorp@amsterdamumc.nl', 'phone': '020-5669111'}], 'overallOfficials': [{'name': 'Max Nieuwdorp, prof dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location AMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Max Nieuwdorp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Max Nieuwdorp', 'investigatorAffiliation': 'Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)'}}}}