Nctid:
NCT06615986
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000064806", "term"=>"Dysbiosis"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M30405", "name"=>"Dysbiosis", "asFound"=>"Dysbiosis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-09", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09-27", "completionDateStruct"=>{"date"=>"2027-05-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-03", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-04-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum", "timeFrame"=>"8 weeks", "description"=>"To assess changes in the microbiome, we will measure the increase in the populations of Lactobacillus plantarum and Bifidobacterium bifidum."}], "secondaryOutcomes"=>[{"measure"=>"Reported intake by the subject and counting the number of remaining supplement", "timeFrame"=>"8 weeks", "description"=>"Measure adherence to the symbiotic supplementation regimen."}, {"measure"=>"Mean change of biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin in plasma", "timeFrame"=>"8 weeks", "description"=>"Assess the effect of synbiotic supplementation on plasma levels."}, {"measure"=>"Fold increase in Lactobacillus or Bifidobacterium over baseline", "timeFrame"=>"8 weeks", "description"=>"Evaluate the impact of synbiotic supplementation on gut integrity."}, {"measure"=>"Number of participants that tolerated symbiotic supllementation", "timeFrame"=>"8 weeks", "description"=>"Assess participant tolerabiltiy related to changes in the gut microbiome to synbiotic supplementation for duration of study"}, {"measure"=>"Number of gastrointestinal symptoms reported by participants using Common Terminology Criteria for Adverse Events version 5.0", "timeFrame"=>"8 weeks", "description"=>"Gastrointestinal symptoms related to changes in the gut microbiome reported by participants using Common Terminology Criteria for Adverse Events version 5.0"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Gut Barrier", "Intestinal Health", "PLASMA LIPIDS", "Artherosclerosis", "Low-Density Lipoprotein (LDL)", "Cholesterol", "Lipoproteins", "Human Milk Oligosaccharides (HMO)", "Gut Microbiota", "Symbiotic"], "conditions"=>["Healthy Volunteers"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_001729-H.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Background:\n\nHuman intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health.\n\nObjective:\n\nTo find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk.\n\nEligibility:\n\nHealthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions).\n\nDesign:\n\nParticipants will have 2 clinic visits.\n\nThe first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study.\n\nEligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person.\n\nThe supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal.\n\nThe second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.", "detailedDescription"=>"Study Description:\n\nThis pilot proof-of-principle (PoP) study will investigate mechanisms of action of a human milk oligosaccharide (HMO)-based synbiotic supplement, Cardiosyn (a combination of prebiotics and pro-biotics). Synbiotics for gut microbiota are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions, and normalizing blood lipids and iron markers in healthy human subjects.\n\nObjectives:\n\nPrimary Objective:\n\nTo measure changes in microbiome determined by the increase of the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.\n\nSecondary Objectives:\n\nMeasure the level of adherence to the symbiotic supplementation.\n\nMeasure the effect of the synbiotic supplementation in plasma.\n\nMeasure the effect of synbiotic supplementation on gut integrity.\n\nTolerability and GI symptoms secondary to gut microbiome changes.\n\nTertiary/Exploratory Objectives:\n\nIdentify possible associations between the gut microbiome change and biomarkers.\n\nEndpoints: Primary Endpoint:\n\nAt least an increase of two-fold in the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.\n\nSecondary Endpoint:\n\nReported intake by the subject and counting the number of the remaining supplement\n\nBiomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin, lipid profile and TMAO\n\nMeasurement of gut integrity marker (serum zonulin) in plasma\n\nNumber of participants that tolerated study supplement for full duration of study\n\nNumber of participants with GI reported symptoms according to CTCAE v5.0\n\nTertiary/Exploratory Endpoints:\n\nMeasurement of changes of microbiome and biomarkers in plasma (16S RNA microbiota analysis initially with potential for more extensive and novel analysis)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n* Healthy males and females between the ages 18 to 99.\n* Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.\n* Subjects taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI discretion).\n* Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion.\n\nEXCLUSION CRITERIA:\n\n* Pregnancy or women currently breastfeeding.\n* Subjects currently on other prebiotics and/or probiotics supplementation.\n* Subjects that are vegetarians or vegans or not on a typical western diet.\n* Subjects planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.\n* Subjects with allergy or known hypersensitivity to any components of the supplement.\n* Subjects with weight changes greater than 20% over the past 3 months.\n* Subjects planning a significant change in diet or exercise levels.\n* Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n* Anticipated surgery during the study period.\n* Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant."}, "identificationModule"=>{"nctId"=>"NCT06615986", "briefTitle"=>"Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis", "orgStudyIdInfo"=>{"id"=>"10001729"}, "secondaryIdInfos"=>[{"id"=>"001729-H"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Cardiosyn in Healthy Volunteers", "description"=>"Participants will receive 2 doses of Cardiosyn daily by mouth (2 sachets) for a total of 16.2 grams. Each does (sachet) is 8.1 grams.", "interventionNames"=>["Dietary Supplement: Cardiosyn"]}], "interventions"=>[{"name"=>"Cardiosyn", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Two sachets by mouth daily. Each dose (sachet) is 8.1 grams. For 2 doses it will be 16.2 grams per person per day.", "armGroupLabels"=>["Cardiosyn in Healthy Volunteers"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "contacts"=>[{"name"=>"NIH Clinical Center Office of Patient Recruitment (OPR)", "role"=>"CONTACT", "email"=>"ccopr@nih.gov", "phone"=>"800-411-1222", "phoneExt"=>"TTY dial 711"}], "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "centralContacts"=>[{"name"=>"Joy Lynne V Freeman", "role"=>"CONTACT", "email"=>"joylynne.freeman@nih.gov", "phone"=>"(301) 480-7632"}, {"name"=>"Marcelo J Amar, M.D.", "role"=>"CONTACT", "email"=>"mamar@mail.nih.gov", "phone"=>"(301) 402-0521"}], "overallOfficials"=>[{"name"=>"Marcelo J Amar, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Heart, Lung, and Blood Institute (NHLBI)"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP", "ICF"], "timeFrame"=>"Starting approximately 6 months after publication and available indefinitely.", "ipdSharing"=>"YES", "description"=>"All IPD that underlie results in a publication", "accessCriteria"=>"Data will be shared through the NHLBI BioData Catalyst, which is a controlled access repository."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
