An interventional study of Postbiotic and Placebo in Healthy, sponsored by The Archer-Daniels-Midland Company. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by The Archer-Daniels-Midland Company · Not applicable, Interventional, and Prevention
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:
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).
The Archer-Daniels-Midland Company is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must either be not of or, if of childbearing potential, must agree to comply with the following requirements:
Exclusion Criteria:
Have a history of alcohol or substance abuse within the 24 months prior to screening, defined as any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 tablets (10mg) per day
Dietary Supplement: Postbiotic
2 tablets (10mg) per day
Dietary Supplement: Placebo
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.
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.
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).
Time frame: Baseline and 4 weeks
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).
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
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).
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
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).
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
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).
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)
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).
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
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).
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)
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).
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
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).
Time frame: Baseline to Weeks 2, 4, and 6; Week 2 to Week 4 and Week 6; Week 4 to Week 6
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6
To evaluate the effect of the postbiotic on Streptococcus mutans counts compared to placebo
Change in S. mutans counts
Time frame: Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6
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.
Time frame: Baseline to Weeks 2 and 4; Week 2 to Week 4 and Week 6; Week 4 to Week 6
To assess Adverse Events (AEs)
Reports of Adverse Events (AEs)
Time frame: Baseline, Weeks 2, 4, and 6
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Archer-Daniels-Midland Company