[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732582":3,"trial-entities:NCT07732582":70,"trial-summary:NCT07732582":74},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":45,"sex":46,"minimum_age":17,"maximum_age":17,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":52,"locations":56,"central_contacts":66,"overall_officials":67,"references":68,"see_also_links":69},"NCT07732582","STUDY00006388","Sjogren's Mini-Pill Oral and Gut Microbiome Study","Exploratory Study on Characterizing Region-Specific Gastrointestinal and Oral Microbiomes in Sjögren's Disease Using Novel Ingestible Mini-Pill Sampling Technology","NOT_YET_RECRUITING","2028-08-31","2026-07","2026-07-29","2026-08-31","Tufts University","OTHER",false,"The goal of this observational study is to characterize and compare region-specific gastrointestinal, stool, oral, and periodontal microbiomes in adults with Sjögren's disease and healthy controls using ingestible mini-pill sampling technology. The study will include adults with Sjögren's disease and healthy control participants enrolled in a parent gastrointestinal microbiome study",null,[19],"Sjogren's Syndrome",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},90,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Mini-Pill","Collection of region-specific gastrointestinal microbiome samples using ingestible mini-pill technology for microbiome characterization and comparison between adults with Sjögren's disease and healthy controls.",[34,35],"Control Group","Sjogren's Group",[37,41],{"measure":38,"description":39,"timeFrame":40},"Microbial","The primary outcome will be overall microbial community composition","3-8 weeks",{"measure":42,"description":43,"timeFrame":44},"Sjogren's Microbiome Relationship","To evaluate the relationship of salivary and periodontal plaque microbiomes in the Sjogren's group to their gut and stool microbiome.","3 weeks",[],"ALL",true,{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion Criteria:\n\nGroup 1: Control\n\n1. Currently enrolled in and willing to share data from the parent study of \"Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling\" at Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University.\n2. Willing to provide saliva and periodontal plaque from the deepest periodontal pocket.\n3. Able to understand study requirements and procedures, and willing to sign informed consent prior to participation.\n\nGroup 2: Sjogren's Cohort\n\n1. Adult Sjogren's Disease participants diagnosed according to the 2016 American European criteria\n2. Willing to donate saliva and periodontal plaque from the deepest periodontal pocket.\n3. Able and willing to perform home stool collection and recovery of GI sampling capsules.\n\nExclusion Criteria\n\nControl Group:\n\n1. Those not participating in parent study, \"Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling\" at HNRCA.\n2. Unable to understand or unwilling to sign the informed consent form.\n3. Any medical conditions requiring antibiotic prophylaxis prior to dental procedures (e.g., certain cardiac conditions, prosthetic joints). Upon interviewing the potential subject, no periodontal sample will be taken. Only saliva samples will be taken in these cases.\n4. Presence of active disease of the hard or soft oral tissues.\n5. History of salivary gland disorders, such as Sjögren's syndrome, sarcoidosis, or prior head and neck radiation therapy.\n6. If a subject needs to undergo new dental or periodontal treatment (including scaling, root planing, or antibiotic irrigation) while enrolled in our study\n\nSjogren's Cohort:\n\n1. Pregnant or breast feeding\n2. Requiring antibiotic prophylaxis before dental procedures\n3. HIV\u002FAIDS, sarcoidosis, or prior head and neck radiation therapy.",[53,54,55],"CHILD","ADULT","OLDER_ADULT",[57],{"facility":58,"city":59,"state":60,"zip":61,"country":62,"geoPoint":63},"Tufts University School of Dental Medicine","Boston","Massachusetts","02111","United States",{"lat":64,"lon":65},42.35843,-71.05977,[],[],[],[],{"nct_id":4,"conditions":71,"biomarkers":73},[72],"Sjogren Syndrome",[],{"nct_id":4,"found":47,"summary":75,"prompt_version":84},{"design":76,"status":77,"heading":6,"summary":78,"follow_up":79,"word_count":80,"commitments":81,"compensation":82,"drugs_mentioned":83},"This interventional study plans to enroll 90 participants, comparing adults with Sjögren's disease to healthy controls.","completed","This study is looking into the connection between Sjögren's disease and the tiny living organisms (microbiome) in your gut, mouth, and on your teeth. Researchers will use a special ingestible mini-pill to collect samples from different parts of your digestive system. They will compare these samples from adults with Sjögren's disease to samples from healthy adults. The main goal is to understand the different types of microbes present and how they might be related to Sjögren's disease. The study aims to enroll 90 participants and is currently unclear on its recruitment status.","The study will measure microbial changes between 3 and 8 weeks, and the relationship between the microbiome and Sjögren's at 3 weeks.",92,"You would provide saliva and plaque samples. The study involves using an ingestible mini-pill to collect samples from your gastrointestinal tract.","Not stated in the trial record.",[31],"v2"]