[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656826":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":73,"studyPopulation":64,"armGroups":74,"interventions":86,"overallOfficials":64,"centralContacts":64,"locations":94,"responsibleParty":118,"collaborators":120,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":64,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":148,"whyStopped":64,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"The Archer-Daniels-Midland Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"To determine the effect of the postbiotic on dental plaque formation compared to placebo","The difference between postbiotic and placebo in change from Baseline to Week 4 in dental plaque score as measured by the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI; range: 0 to 5, with lower scores indicating less plaque accumulation and a better outcome).","Baseline and 4 weeks",[14,18,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"To evaluate the effect of the postbiotic on dental plaque formation compared to placebo","Change in dental plaque formation as measured by the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI; range: 0 to 5, with lower scores indicating less plaque accumulation and a better outcome).","Baseline to Week 2 and Week 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6",{"measure":19,"description":20,"timeFrame":21},"To evaluate the effect of the postbiotic on dental calculus formation compared to placebo","Change in dental calculus formation as measured by the Volpe-Manhold Index (VMI; units: mm, with lower scores indicating less calculus accumulation and a better outcome).","Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6",{"measure":23,"description":24,"timeFrame":21},"To evaluate the effect of the postbiotic on gingival bleeding compared to placebo, as measured by an objective clinical assessment","Change in gingival bleeding assessed by bleeding on probing (BOP), measured using the Ainamo and Bay method and defined as the % of sites with bleeding on probing out of the total number of sites examined (units: %, with range 0 to 100 % and lower percentages indicating a lower prevalence of gingival bleeding and a better outcome).",{"measure":26,"description":27,"timeFrame":21},"To evaluate the effect of the postbiotic on gingival bleeding compared to placebo, as assessed through participant self-report","Change in participant-reported gingival bleeding, measured using the Gingival Bleeding Self-Assessment Questionnaire (GBSAQ; lower scores indicate less gingival bleeding and a better outcome).",{"measure":29,"description":30,"timeFrame":21},"To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by probing pocket depth (PPD)","Change in periodontal health as assessed by full-mouth periodontal charting (six sites per tooth), measuring Probing Pocket Depth (PPD), summarized as the % of sites with PPD ≥ 4 mm and ≥ 5 mm (units: %, range 0 to 100%, with lower percentages indicating a lower prevalence of periodontal pockets and a better outcome).",{"measure":32,"description":33,"timeFrame":21},"To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by gingival recession","Change in periodontal health as assessed by full-mouth periodontal charting (six sites per tooth), measuring gingival recession (units: mm, lower values indicate less gingival recession and a better outcome).",{"measure":35,"description":36,"timeFrame":21},"To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by Clinical Attachment Level (CAL)","Change in periodontal health as assessed by full-mouth periodontal charting (six sites per tooth), measuring Clinical Attachment Level (CAL; units: mm, lower values indicate less periodontal attachment loss and a better outcome).",{"measure":38,"description":39,"timeFrame":21},"To evaluate the effect of the postbiotic on gingival inflammation compared to placebo","Change in gingival inflammation as measured by the Löe-Silness Gingival Index (GI; range 0 to 3, with lower scores indicating lower severity of gingival inflammation and a better outcome).",[41,45,48,51,54,57],{"measure":42,"description":43,"timeFrame":44},"Change in oral microbiome composition following postbiotic intervention compared with placebo","To evaluate the effect of the postbiotic compared with placebo on oral microbiome composition, as measured by changes in alpha diversity and beta diversity over time.","Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6",{"measure":46,"description":47,"timeFrame":44},"Change in the abundance of beneficial versus pathogenic oral bacterial species following postbiotic intervention compared with placebo","To evaluate the effect of the postbiotic compared with placebo on the abundance of beneficial versus pathogenic oral bacterial species over time. Significant changes will be reported using fold change and adjusted p-values.",{"measure":49,"description":50,"timeFrame":44},"Changes in the abundances of oral microbial genes contained in specific functional modules following postbiotic intervention compared with placebo","To evaluate the effect of the postbiotic compared with placebo on changes in the abundance of genes within specific functional modules defined by the KEGG database. Gene Set Enrichment Analysis (GSEA) will be performed to determine which modules are enriched by the postbiotic throughout the study. Significant associations will be reported with the Normalized Enrichment score (NES) and adjusted p-values.",{"measure":52,"description":53,"timeFrame":44},"To evaluate the effect of the postbiotic on Streptococcus mutans counts compared to placebo","Change in S. mutans counts",{"measure":55,"description":56,"timeFrame":44},"Change in the abundance of predefined oral microbial species associated with halitosis following postbiotic intervention as compared to placebo","To evaluate the effect of the postbiotic on the abundance of predefined oral bacterial species associated with halitosis compared with placebo. Changes in bacterial abundance over time will be compared between treatment groups.",{"measure":58,"description":59,"timeFrame":60},"To assess Adverse Events (AEs)","Reports of Adverse Events (AEs)","Baseline, Weeks 2, 4, and 6",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":64,"timePerspective":64,"maskingInfo":66},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":67,"maskingDescription":68,"whoMasked":69},"TRIPLE","Statistical Team",[70,71,72],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Participants will attend clinic visits at the beginning of the study and at weeks 2, 4, and 6. During these visits, examinations will be performed to assess the health of their teeth and gingivae (gums). Saliva and plaque samples will also be collected to investigate how the postbiotic may affect the oral microbiome (the bacteria that naturally live in the mouth).",[75,81],{"label":76,"type":77,"description":78,"interventionNames":79},"Postbiotic","EXPERIMENTAL","2 tablets (10mg) per day",[80],"Dietary Supplement: Postbiotic",{"label":82,"type":83,"description":78,"interventionNames":84},"Placebo","PLACEBO_COMPARATOR",[85],"Dietary Supplement: Placebo",[87,91],{"type":88,"name":76,"description":89,"armGroupLabels":90,"otherNames":64},"DIETARY_SUPPLEMENT","1 tablet to be taken after brushing in the morning and 1 tablet to be taken after brushing in the evening for 6 weeks. Tablets should be chewed until fully dissolved. The active intervention provides 10mg of heat-treated postbiotic per day. The postbiotic is manufactured by heat treatment of a probiotic preparation equivalent to 3.0 × 10\\^9 CFU.",[76],{"type":88,"name":82,"description":92,"armGroupLabels":93,"otherNames":64},"1 tablet to be taken after brushing in the morning and 1 tablet to be taken after brushing in the evening for 6 weeks. Tablets should be chewed until fully dissolved. The placebo tablet is matched to the active tablet in packaging, appearance, and taste.",[82],[95],{"facility":96,"status":64,"city":97,"state":98,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Nutrasource Pharmaceutical and Nutraceutical Services, Inc.","Guelph","Ontario","N1G 0B4","Canada","CA",{"type":103,"coordinates":104},"Point",[105,106],-80.25599,43.54594,{"lat":106,"lon":105},[109,115],{"name":110,"role":111,"phone":112,"phoneExt":113,"email":114},"Bisma Sharif, MD","CONTACT","226-706-8903","124","bsharif@nutrasource.ca",{"name":116,"role":117,"phone":64,"phoneExt":64,"email":64},"Anthony Bier, MD","PRINCIPAL_INVESTIGATOR",{"type":119,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR",[121],{"name":96,"class":122},"NETWORK","100656826","the-effect-of-a-postbiotic-on-oral-health-in-healthy-adults-100656826",false,"NCT07830862","The Effect of a Postbiotic on Oral Health in Healthy Adults","A Randomised, Triple-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Chewable Postbiotic Tablet on Oral Health in Healthy Adults","LOOFAH2","Inclusion Criteria:\n\n1. Adults who are between 18 - 65 years of age (inclusive) at the time of signing the informed consent.\n2. In otherwise good general health, as deemed by the investigator (based on review of medical history, vital signs, and physical examination performed at screening and\u002For before the first dose of the study product).\n3. Are able to consume the study product completely within the specified timeframe.\n4. Have a body mass index (BMI) between 18.5 to 29.9 kg\u002Fm\\^2 (inclusive).\n5. Have ≥24 natural, non-prosthetic teeth present at screening.\n6. Have good oral and dental health, as determined by examination at screening.\n7. Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study.\n8. Agrees to abstain from oral sex for at least 24 hours prior to each study visit.\n9. Agree to follow the restrictions on concomitant treatments.\n10. Agree to follow the restrictions on lifestyle, including oral hygiene.\n11. Participants must either be not of childbearing potential or, if of childbearing potential, must agree to comply with the following requirements:\n\n    * Have a negative pregnancy test at the baseline visit prior to administration of the study product.\n    * Use a highly effective method of contraception.\n12. Female-born participants who are using hormonal contraception have been using hormonal contraception for at least 12 months.\n13. Female-born participants must agree to abstain from ovum donation, from screening through at least 30 days after the last dose of study product.\n14. Willing and able to comply with all study requirements and restrictions, including consumption of study products, biological sample collection procedures, and adherence to the study visit schedule; able to understand and complete questionnaires, provide written informed consent, and voluntarily participate in all study-related procedures.\n\nExclusion Criteria:\n\n1. Individuals who are intending to breastfeed, intending to conceive, or are pregnant as confirmed by a positive pregnancy test during study visits.\n2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.\n3. Have periodontal probing depths of ≥4 mm at any site at the screening visit.\n4. Have treatment-requiring oral diseases, including dental caries, gingivitis, or periodontitis.\n5. Have dental prosthetic or orthodontic devices, temporary or permanent, that, in the Investigator's discretion, are likely to interfere with study outcomes (e.g., bridges, retainers, implants).\n6. Have a history of use of antibiotics or acid sequestrants (e.g., cholestyramine, colestipol) within 3 months prior to the Screening Visit (Visit 1), or plan to use any of these during the study.\n7. Have Type I diabetes or Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease (\"uncontrolled\" defined as being unmedicated, having an unstable use of medication within 3 months prior to screening, or having a stable use of medication for 3 months but still having uncontrolled conditions).\n8. Individuals with any abnormality, obstruction, or disorder of the gastrointestinal tract that may preclude swallowing (e.g., dysphagia) or impair gastrointestinal motility, digestion, or absorption (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease \\[including Crohn's disease or ulcerative colitis\\], chronic pancreatitis, or steatorrhea). In addition, any history of gastrointestinal surgery or anatomical abnormality that, in the opinion of the Investigator, may affect the oral absorption of the study product.\n9. Have a history of heart\u002Fcardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment\u002Fdisease, immune disorders and\u002For immunocompromise (i.e., HIV\u002FAIDS).\n10. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.\n11. Are receiving treatments for or have been hospitalised in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).\n12. Reports a clinically significant illness during the 28 days before the first dose of study product.\n13. Major surgery in 3 months prior to screening or planned major surgery during the study.\n14. Current users of tobacco products, including smoking or smokeless forms, or former users within 12 months prior to screening.\n15. Have a history of alcohol or substance abuse within the 24 months prior to screening, defined as any of the following:\n\n    * Use of recreational drugs (e.g., cocaine, methamphetamine, marijuana) or nicotine dependence\n    * High-risk alcohol consumption, defined as consuming excessive alcohol based on gender-specific thresholds (four or more drinks on any single day or eight or more drinks per week for women; five or more drinks on any single day or 15 or more drinks per week for men)\n    * Hospitalisation for alcohol or substance abuse in an inpatient or outpatient intervention program\n    * Any use that, in the opinion of the investigator, may be of concern for the study\n16. Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 90 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.\n17. Any other medical condition\u002Fsituation or use of medications\u002Fsupplements\u002Ftherapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.",true,"ALL","18 Years","65 Years",{"count":136,"type":137},56,"ESTIMATED","INTERVENTIONAL",[140],"NA","The goal of this randomised, placebo-controlled trial is to determine the effect of a chewable postbiotic tablet on the oral health of male and female healthy adults under conditions of short term oral-neglect (a short, temporary period during which participants do not perform their usual oral hygiene practices, such as tooth brushing and flossing).\n\nThe main questions the study aims to answer are:\n\n1. Does postbiotic ingestion impact dental plaque accumulation, gingival (gum) inflammation, and periodontal health compared with placebo?\n2. Does postbiotic ingestion alter the oral microbiome composition compared with placebo?",[143],"Healthy",[145,76,146,147],"Oral health","Oral microbiome","Chewable tablet","NOT_YET_RECRUITING","2026-09-15",{"date":151,"type":152},"2026-09-21","ACTUAL",{"date":154,"type":137},"2026-10-01",{"date":156,"type":137},"2027-06-01",{"name":5,"class":6},1]