Nctid:
NCT06617364
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007787", "term"=>"Lactose Intolerance"}], "ancestors"=>[{"id"=>"D008286", "term"=>"Malabsorption Syndromes"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D002239", "term"=>"Carbohydrate Metabolism, Inborn Errors"}, {"id"=>"D008661", "term"=>"Metabolism, Inborn Errors"}, {"id"=>"D030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}], "browseLeaves"=>[{"id"=>"M10805", "name"=>"Lactose Intolerance", "asFound"=>"Lactose Intolerance", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M11278", "name"=>"Malabsorption Syndromes", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M11641", "name"=>"Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M5498", "name"=>"Carbohydrate Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-11-11", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2025-05-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-13", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-15", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"ICG-Signal in the intestinal tract", "timeFrame"=>"1 day", "description"=>"measured be MSOT"}], "secondaryOutcomes"=>[{"measure"=>"Hydrogen breath test results", "timeFrame"=>"1 day", "description"=>"measured in ppm"}, {"measure"=>"MRI", "timeFrame"=>"1 day", "description"=>"peristaltic metrics"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["MSOT", "lactose intolerance", "pediatric", "ICG", "gastrointestinal transit"], "conditions"=>["Lactose Intolerance"]}, "descriptionModule"=>{"briefSummary"=>"The study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography (MSOT) in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance. These patients exhibit varying clinical symptoms and different results from the hydrogen breath test (H2 breath test).\n\nLactose intolerance is caused by a deficiency in the enzyme lactase, which is responsible for breaking down lactose into glucose and galactose. Without this breakdown, lactose is fermented by colon bacteria, leading to symptoms such as bloating and diarrhea. The prevalence of lactose intolerance is increasing, especially among children, and the current diagnostic gold standard is the hydrogen breath test, which, while specific, has limitations in sensitivity.\n\nMSOT could fill this diagnostic gap by non-invasively measuring intestinal transit time and providing a more objective assessment of the condition.\n\nThe study will compare MSOT results with H2 breath test outcomes, particularly focusing on patients with varying disease durations and activity levels.\n\nAdditionally, participants are offered an optional MRI examination, which can be used to measure intestinal motility. This helps to further quantify the results of the MSOT examination and discover new findings regarding the extent of the disease.\n\nMSOT could improve the sensitivity of lactose intolerance diagnosis, differentiate it from other conditions, and offer insights into disease management over time."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Written informed consent of the subject\n* Written informed consent of the subject\\'s legal guardian\n* Suspicion or diagnosis of lactose intolerance\n* Age 6 to 18 years\n\nGeneral Exclusion Criteria:\n\n* Pregnancy\n* Breastfeeding mothers\n* Tattoo in the examination area\n* Subcutaneous fat tissue over 3 cm\n* Known hypersensitivity to ICG, sodium iodide, or iodine\n* Hyperthyroidism, focal or diffuse thyroid autonomy\n* Recent treatment for thyroid function assessment involving radioactive iodine (within two weeks before or after the study)\n* Impaired renal function\n* Use of the following medications: beta-blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite\n\nMRI Exclusion Criteria:\n\n* General contraindications for MRI examinations (e.g., electrical implants such as pacemakers or infusion pumps, etc.)\n* Severe claustrophobia"}, "identificationModule"=>{"nctId"=>"NCT06617364", "briefTitle"=>"MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Erlangen-Nürnberg Medical School"}, "officialTitle"=>"Contrast Enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Intestinal Transit Time in Lactose Intolerance Patients", "orgStudyIdInfo"=>{"id"=>"MSOT_ICG_LI"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"pediatric patients with suspected lactose intolerance", "description"=>"On the one hand the patients will undergo the hydrogen breath test and on the other their gastrointestinal transit time will be measured using MSOT and ICG contrast agent.", "interventionNames"=>["Procedure: gastrointestinal transit time measurement using MSOT and ICG contrast agent"]}], "interventions"=>[{"name"=>"gastrointestinal transit time measurement using MSOT and ICG contrast agent", "type"=>"PROCEDURE", "description"=>"The subject arrives at the clinic in the morning, fasting according to the preparation instructions from the Childrens Hospital Erlangen for the H2 breath test. Before taking the liquid containing lactose and ICG, the first measurement is performed using MSOT, followed by the H2 breath test. After the liquid to be detected is fully consumed, the second H2 breath test measurement, which only takes a few minutes, is conducted. According to the official guidelines of the Childrens Hospital Erlangen, the hydrogen concentration in the breath is measured at 30-minute intervals. During the 30-minute breaks, further MSOT measurements are carried out, also at 30-minute intervals. Each of these only takes about 10 minutes, they do not interfere with the H2 breath test measurement routine. After the ninth and final H2 breath test measurement a final MSOT examination is conducted. Afterwards participants are offered an optional MRI examination, which can be used to measure intestinal motility.", "armGroupLabels"=>["pediatric patients with suspected lactose intolerance"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"91054", "city"=>"Erlangen", "state"=>"Bavaria", "status"=>"RECRUITING", "country"=>"Germany", "contacts"=>[{"name"=>"Adrian Regensburger, PD Dr. med.", "role"=>"CONTACT", "email"=>"adrian.regensburger@uk-erlangen.de", "phone"=>"+4991318541175"}, {"name"=>"Felix Wachter", "role"=>"CONTACT", "email"=>"felix.wachter@uk-erlangen.de"}, {"name"=>"Adrian Regensburger, PD Dr. med.", "role"=>"CONTACT"}], "facility"=>"University Hospital Erlangen", "geoPoint"=>{"lat"=>49.59099, "lon"=>11.00783}}], "centralContacts"=>[{"name"=>"Ferdinand Knieling, PD Dr. med. Dr. rer. biol. hum", "role"=>"CONTACT", "email"=>"ferdinand.knieling@uk-erlangen.de", "phone"=>"+4991318533118"}, {"name"=>"Adrian Regensburger, PD Dr. med. Dr. rer. biol. hum", "role"=>"CONTACT", "email"=>"adrian.regensburger@uk-erlangen.de", "phone"=>"+49 9131 85-33118"}], "overallOfficials"=>[{"name"=>"Adrian Regensburger, PD Dr. med. Dr. rer. biol. hum", "role"=>"STUDY_CHAIR"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Erlangen-Nürnberg Medical School", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PD Dr. med. Dr. rer. biol. hum.", "investigatorFullName"=>"Ferdinand Knieling", "investigatorAffiliation"=>"University Hospital Erlangen"}}}}
