HealthyLOOFAH2NCT07830862
The Effect of a Postbiotic on Oral Health in Healthy Adults
A study testing Postbiotic in people with Healthy, run by The Archer-Daniels-Midland Company at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Postbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Guelph, Ontario, N1G 0B4
Bisma Sharif, MD, 226-706-8903 ext. 124, bsharif@nutrasource.ca
Anthony Bier, MD
About this study
Official title: A Randomised, Triple-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Chewable Postbiotic Tablet on Oral Health in Healthy Adults
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?
Read the detailed description
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).
- Conditions
- Healthy
- Being tested
- Postbiotic, Placebo
- Keywords
- Oral health, Postbiotic, Oral microbiome, Chewable tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Postbiotic | Experimental | 2 tablets (10mg) per day Receives: Dietary Supplement: Postbiotic |
| Placebo | Placebo comparator | 2 tablets (10mg) per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 4 weeks
Secondary outcomes (8)
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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)
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).
Measured: 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
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).
Measured: 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)
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).
Measured: 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
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).
Measured: Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830862
- Sponsor's protocol ID
- CTB2024TN401
- Acronym
- LOOFAH2
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Triple-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Chewable Postbiotic Tablet on Oral Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT07830862
- Acronym / sponsor ID
- LOOFAH2 / CTB2024TN401
- Conditions
- Healthy
- Keywords
- Oral health, Postbiotic, Oral microbiome, Chewable tablet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postbiotic | Experimental | Dietary Supplement: Postbiotic2 tablets (10mg) per day |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 tablets (10mg) per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postbiotic1 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. | Dietary supplement | Postbiotic |
| Placebo1 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. | Dietary supplement | Placebo |
Primary outcome
To determine the effect of the postbiotic on dental plaque formation compared to placebo
Time frame: 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).
8 secondary outcomes
To evaluate the effect of the postbiotic on dental plaque formation compared to placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Guelph, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic in people with Healthy, run by The Archer-Daniels-Midland Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of the postbiotic on dental plaque formation compared to placebo (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.