Trial Outcomes & Findings for Determining the Viability a Lozenge Dosage for Probiotics (NCT NCT06819761)
NCT ID: NCT06819761
Last Updated: 2026-06-16
Results Overview
Oral inflammatory load (OIL) is measured via oral neutrophil count in oral rinse samples (oPMN). Post-transplantation values (Day 7) are normalized to each participant's baseline (Day 0) value to evaluate the change in OIL. For normalization, each participant's baseline OIL was set to 1 by dividing the baseline neutrophil count by itself. Post-transplantation OIL values were then divided by the participants baseline to calculate fold change.
COMPLETED
NA
8 participants
Baseline (day 0) and day 7
2026-06-16
Participant Flow
8 volunteers were enrolled.
Participant milestones
| Measure |
Receives Probiotic Lozenge
This study is an open-label, single-arm, exploratory pilot study to be completed over 7 days with 8-10 participants. Participants will self-administer one lozenge containing S. salivarius SALI-10 (10 billion CFU/lozenge) each night after brushing and before bed. Every participant will be given 7 SALI-10 lozenges.
The aim of this study is to determine the short-term ability of the Streptococcus salivarius SALI-10 lozenges delivery system to modify the human oral microbiome composition and Oral Inflammatory Load (OIL). Specifically, the investigators aim to:
* Evaluate the change in Oral Inflammatory Load (OIL)
* Assess successful colonization of SALI-10
* Assess changes in disease associated taxa.
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Receives Probiotic Lozenge
n=8 Participants
Oral microbiome samples and oral rinse samples were collected at baseline (pre-transplantation) and after 7 days of lozenge use (post-transplantation). To evaluate the potential anti-inflammatory effects of SALI-10, oral inflammatory load (OIL) was measured in oral rinse samples collected before and after the intervention. For the baseline. the following was measured:
1. Oral inflammatory load (OIL)
2. Successful colonization of SALI-10 was analyzed by qPCR targeting the srnA2 gene (encoding for SrnA2 phosphorylated lantibiotic). Prior to intervention, srnA2 was undetectable in 6 out of 8 subjects.
3. Evaluated pathogen suppression by quantifying changes in the abundance of disease-associated taxa.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=8 Participants
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Age, Categorical
Between 18 and 65 years
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8 Participants
n=8 Participants
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Age, Categorical
>=65 years
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0 Participants
n=8 Participants
|
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Sex: Female, Male
Female
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4 Participants
n=8 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=8 Participants
|
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SALI-10 colonization levels at baseline
|
0.8287 log10(copies/mL)
STANDARD_DEVIATION 1.6001 • n=8 Participants
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Relative abundance of P. gingivalis at baseline
|
0.4195 relative abundance (proportion)
STANDARD_DEVIATION 0.0767 • n=8 Participants
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Relative abundance of T. forsythia at baseline
|
0.4454 relative abundance (proportion)
STANDARD_DEVIATION 0.1006 • n=8 Participants
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Relative abundance of P. micra at baseline
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0.5323 relative abundance (proportion)
STANDARD_DEVIATION 0.0695 • n=8 Participants
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Relative abundance of F. nucleatum at baseline
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0.6655 relative abundance (proportion)
STANDARD_DEVIATION 0.0911 • n=8 Participants
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PRIMARY outcome
Timeframe: Baseline (day 0) and day 7Population: One participant was unable to provide an OPMN sample.
Oral inflammatory load (OIL) is measured via oral neutrophil count in oral rinse samples (oPMN). Post-transplantation values (Day 7) are normalized to each participant's baseline (Day 0) value to evaluate the change in OIL. For normalization, each participant's baseline OIL was set to 1 by dividing the baseline neutrophil count by itself. Post-transplantation OIL values were then divided by the participants baseline to calculate fold change.
Outcome measures
| Measure |
Receives Probiotic Lozenge
n=7 Participants
Receives Probiotic Lozenge for 7 days after baseline measurements are collected.
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|---|---|
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Change in Oral Inflammatory Load (OIL)
baseline
|
1 fold change
Standard Error 0 • Interval 42.0 to 50.0
|
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Change in Oral Inflammatory Load (OIL)
day 7
|
0.573 fold change
Standard Error 0.087
|
PRIMARY outcome
Timeframe: Baseline (day 0) and day 7Quantification of SALI-10 colonization using qPCR targeting the srnA2 gene. Samples were collected at baseline (Day 0) and post-transplantation (Day 7). The srnA2 gene encodes for phosphorylated lantibiotic synthesized by S.salivarius SALI-10
Outcome measures
| Measure |
Receives Probiotic Lozenge
n=8 Participants
Receives Probiotic Lozenge for 7 days after baseline measurements are collected.
|
|---|---|
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Change in SALI-10 Colonization Levels
baseline
|
0.829 log10(copies/mL)
Standard Error 0.566
|
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Change in SALI-10 Colonization Levels
Day 7
|
3.344 log10(copies/mL)
Standard Error 0.377
|
PRIMARY outcome
Timeframe: baseline (day 0) and day 7Evaluation of pathogen suppression by quantifying the relative gene abundance of periodontal-disease-associated taxa (e.x. P. gingivalis, T. forsythia, P. micra and F. nucleatum) via qPCR. Relative gene abundance is expressed as the proportion of target bacterial 16s rRNA gene copies relative to the total bacterial 16s rRNA gene copies per mL. The measure reports the actual proportion at baseline and at day 7.
Outcome measures
| Measure |
Receives Probiotic Lozenge
n=8 Participants
Receives Probiotic Lozenge for 7 days after baseline measurements are collected.
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|---|---|
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Changes in the Relative Abundance of P. Gingivalis
day 7 P. gingivalis
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0.362 Proportion of P. gingivalis gene copies
Standard Error 0.028
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Changes in the Relative Abundance of P. Gingivalis
baseline P. gingivalis
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0.420 Proportion of P. gingivalis gene copies
Standard Error 0.028
|
PRIMARY outcome
Timeframe: Baseline (day 0) and day 7Evaluation of pathogen suppression by quantifying the relative gene abundance of periodontal-disease-associated taxa (e.x. P. gingivalis, T. forsythia, P. micra and F. nucleatum) via qPCR. Relative gene abundance is expressed as the proportion of target bacterial 16s rRNA gene copies relative to the total bacterial 16s rRNA gene copies per mL. The measure reports the actual proportion at baseline and at day 7.
Outcome measures
| Measure |
Receives Probiotic Lozenge
n=8 Participants
Receives Probiotic Lozenge for 7 days after baseline measurements are collected.
|
|---|---|
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Changes in the Relative Abundance of T. Forsythia
baseline T. forsythia
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0.445 Proportion of T. forsythia gene copies
Standard Error 0.034
|
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Changes in the Relative Abundance of T. Forsythia
day 7 T. forsythia
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0.382 Proportion of T. forsythia gene copies
Standard Error 0.036
|
PRIMARY outcome
Timeframe: Baseline (day 0) and day 7Evaluation of pathogen suppression by quantifying the relative gene abundance of periodontal-disease-associated taxa (e.x. P. gingivalis, T. forsythia, P. micra and F. nucleatum) via qPCR. Relative gene abundance is expressed as the proportion of target bacterial 16s rRNA gene copies relative to the total bacterial 16s rRNA gene copies per mL. The measure reports the actual proportion at baseline and at day 7.
Outcome measures
| Measure |
Receives Probiotic Lozenge
n=8 Participants
Receives Probiotic Lozenge for 7 days after baseline measurements are collected.
|
|---|---|
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Changes in the Relative Abundance of P. Micra
baseline P. micra
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0.532 Proportion of P. micra gene copies
Standard Error 0.025
|
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Changes in the Relative Abundance of P. Micra
day 7 P. micra
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0.395 Proportion of P. micra gene copies
Standard Error 0.029
|
PRIMARY outcome
Timeframe: Baseline (day 0) and day 7Evaluation of pathogen suppression by quantifying the relative gene abundance of periodontal-disease-associated taxa (e.x. P. gingivalis, T. forsythia, P. micra and F. nucleatum) via qPCR. Relative gene abundance is expressed as the proportion of target bacterial 16s rRNA gene copies relative to the total bacterial 16s rRNA gene copies per mL. The measure reports the actual proportion at baseline and at day 7.
Outcome measures
| Measure |
Receives Probiotic Lozenge
n=8 Participants
Receives Probiotic Lozenge for 7 days after baseline measurements are collected.
|
|---|---|
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Changes in the Relative Abundance of F. Nucleatum
baseline F. nucleatum
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0.666 Proportion of F. nucleatum gene copies
Standard Error 0.03
|
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Changes in the Relative Abundance of F. Nucleatum
day 7 F. nucleatum
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0.595 Proportion of F. nucleatum gene copies
Standard Error 0.043
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Adverse Events
Receives Probiotic Lozenge
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place