The Effect of a Postbiotic on Oral Health in Healthy Adults

NCT07830862 | Not Yet Recruiting

• 1 other identifier: CTB2024TN401
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Does postbiotic ingestion impact dental plaque accumulation, gingival (gum) inflammation, and periodontal health compared with placebo?
2. 2.Does postbiotic ingestion alter the oral microbiome composition compared with placebo?

Conditions

Healthy

Keywords

Oral health; Postbiotic; Oral microbiome; Chewable tablet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

Other Outcomes (6)

• Change in oral microbiome composition following postbiotic intervention compared with placebo

  Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6

• Change in the abundance of beneficial versus pathogenic oral bacterial species following postbiotic intervention compared with placebo

  Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6

• Changes in the abundances of oral microbial genes contained in specific functional modules following postbiotic intervention compared with placebo

  Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6

Study Arms (2)

Postbiotic

EXPERIMENTAL

2 tablets (10mg) per day

Dietary Supplement: Postbiotic

Placebo

PLACEBO COMPARATOR

2 tablets (10mg) per day

Dietary Supplement: Placebo

Interventions

Postbiotic 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.

Postbiotic

Placebo 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 placebo tablet is matched to the active tablet in packaging, appearance, and taste.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Guelph, Ontario, N1G 0B4, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistical Team
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)