NCT07830862尚未招募不适用
A Randomised, Triple-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Chewable Postbiotic Tablet on Oral Health in Healthy Adults
The Archer-Daniels-Midland Company1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To determine the effect of the postbiotic on dental plaque formation compared to placebo
研究概览
简要总结
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).
The main questions the study aims to answer are:
- Does postbiotic ingestion impact dental plaque accumulation, gingival (gum) inflammation, and periodontal health compared with placebo?
- Does postbiotic ingestion alter the oral microbiome composition compared with placebo?
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Statistical Team
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults who are between 18 - 65 years of age (inclusive) at the time of signing the informed consent.
- •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/or before the first dose of the study product).
- •Are able to consume the study product completely within the specified timeframe.
- •Have a body mass index (BMI) between 18.5 to 29.9 kg/m^2 (inclusive).
- •Have ≥24 natural, non-prosthetic teeth present at screening.
- •Have good oral and dental health, as determined by examination at screening.
- •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.
- •Agrees to abstain from oral sex for at least 24 hours prior to each study visit.
- •Agree to follow the restrictions on concomitant treatments.
- •Agree to follow the restrictions on lifestyle, including oral hygiene.
- •Participants must either be not of childbearing potential or, if of childbearing potential, must agree to comply with the following requirements:
- •Have a negative pregnancy test at the baseline visit prior to administration of the study product.
- •Use a highly effective method of contraception.
- •Female-born participants who are using hormonal contraception have been using hormonal contraception for at least 12 months.
- •Female-born participants must agree to abstain from ovum donation, from screening through at least 30 days after the last dose of study product.
- •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.
排除标准
- •Individuals who are intending to breastfeed, intending to conceive, or are pregnant as confirmed by a positive pregnancy test during study visits.
- •Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- •Have periodontal probing depths of ≥4 mm at any site at the screening visit.
- •Have treatment-requiring oral diseases, including dental caries, gingivitis, or periodontitis.
- •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).
- •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.
- •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).
- •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.
- •Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromise (i.e., HIV/AIDS).
- •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.
- •Are receiving treatments for or have been hospitalised in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
- •Reports a clinically significant illness during the 28 days before the first dose of study product.
- •Major surgery in 3 months prior to screening or planned major surgery during the study.
- •Current users of tobacco products, including smoking or smokeless forms, or former users within 12 months prior to screening.
- •Have a history of alcohol or substance abuse within the 24 months prior to screening, defined as any of the following:
- •Use of recreational drugs (e.g., cocaine, methamphetamine, marijuana) or nicotine dependence
- •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)
- •Hospitalisation for alcohol or substance abuse in an inpatient or outpatient intervention program
- •Any use that, in the opinion of the investigator, may be of concern for the study
- •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.
- •Any other medical condition/situation or use of medications/supplements/therapies 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.
研究组 & 干预措施
Postbiotic
Experimental
2 tablets (10mg) per day
干预措施: Postbiotic (Dietary Supplement)
Placebo
Placebo Comparator
2 tablets (10mg) per day
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
To determine the effect of the postbiotic on dental plaque formation compared to placebo
时间窗: Baseline and 4 weeks
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).
次要结局
- To evaluate the effect of the postbiotic on dental plaque formation compared to placebo(Baseline to Week 2 and Week 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on dental calculus formation compared to placebo(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on gingival bleeding compared to placebo, as measured by an objective clinical assessment(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on gingival bleeding compared to placebo, as assessed through participant self-report(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by probing pocket depth (PPD)(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by gingival recession(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on periodontal health compared to placebo, as assessed by Clinical Attachment Level (CAL)(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
- To evaluate the effect of the postbiotic on gingival inflammation compared to placebo(Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary DiseaseCOPD (Chronic Obstructive Pulmonary Disease)COPDNCT07285122Atisama Therapeutics105
尚未招募
2/3 期
to find the effectiveness of homoeopathy in sleeplessness versus placebo trialCTRI/2025/10/095620Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur60
尚未招募
3 期
A study comparing capecitabine with megestrol acetate or placebo in patients with hormone receptor-positive, HER2-negative metastatic breast cancer (CAMEO Study)CTRI/2025/09/094986Tata Memorial Hospital366
招募中
2 期
Efficacy and Safety of QD202 in Participants With Acute Ischemic Stroke Undergoing Thrombolysis Excluding Endovascular ThrombectomyNCT07581210Shanghai QuietD Biotechnology Co., Ltd.120
进行中（未招募）
不适用
A placebo-controlled, blinded study to evaluate the functionality and safety of grapefruit enzyme fermentation extract (KL-GEFE, Nunaezone) on improving eye fatigue and drynessDiseases of the eye and adnexaKCT0012279Dankook Univeristy Hospital68