Healthy AdultsNCT04492631
Safety of an Oral Probiotic in Healthy Adults
A study testing Streptococcus salivarius DB-B5 in people with Healthy Adults, run by Dose Biosystems Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of an oral probiotic in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Streptococcus salivarius DB-B5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 21 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Are adults, 18 to 65 years of age and in good general health and good oral health (no active or uncontrolled diseases or conditions);
- Have a body mass index (BMI) range of 18.5 - 35 kg/m^2;
- Have no known food allergies or intolerances;
- Have normal or acceptable to the Investigator vital signs (blood pressure, heart rate, respiratory rate, temperature) at screening and Day -1 and normal laboratory values and physical exam findings at screening;
- Agree not to make any major changes to their diet during the study;
- Read and sign the Research Subject Information and Consent Form;
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- Are willing to use the assigned products according to instructions, attend scheduled appointments, and complete the study;
- Are males and females who agree to use medically acceptable contraception (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation; abstinence or vasectomies are acceptable if the female subject agrees to implement two of the other acceptable methods of birth control if her lifestyle/partner changes) for the duration of the study and 30 days after study completion and attest to having used it for three months prior to screening, if of child-bearing potential;
- If subject is a female of child-bearing potential, agrees to submit to a urine pregnancy test (UPT) at screening, Day -1 and at the end of study / early termination visit.
Who cannot join
- Have self-reported history of active or chronic dental or medical disease;
- Are prone to gas, bloating, or diarrhea;
- Have received antibiotic treatment in the three months prior to Day 1 or are unwilling to refrain from antibiotic use during the study;
- Used probiotic supplements or consumed probiotic rich foods such as yogurt or kefir within 30 days prior to Day 1 or are unwilling to refrain from the use of probiotic supplements or probiotic rich foods for the duration of the study, even if they are for non-oral health reasons (e.g., vaginal or gut health probiotics);
- Are pregnant, planning to become pregnant during the study period, or are breastfeeding a child;
- Self-reported current users of tobacco products, vaping products, cannabis, and/or nicotine replacement therapy (gums, lozenges, sprays, etc.);
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- Frequent users of alcohol, defined as consumption of 21 units or more of alcoholic beverage per week (21 units = 6 L of beer, 2.5 L of wine, or 500 mL of spirits);
- Used over-the-counter (OTC) laxatives or any other medications, supplements, or products that, in the opinion of the Investigator, could influence the endpoints in this study within 30 days prior to Day 1 or are unwilling to refrain from the use of these products for the duration of the study;
- Have chronic or acute illness such as heart disease, diabetes, cancer, autoimmune conditions, or history of human immunodeficiency virus (HIV) that, in the opinion of the Investigator, could impact the outcome of the study;
- Have any other condition or situation that may increase the risk associated with study participation or may interfere with the study results, in the opinion of the Investigator;
- Are unwilling or unable to provide informed consent and follow study procedures;
- Have participated in any clinical study within the 30 days prior to Day 1;
- Are clinical site personnel or relative or partner of clinical site personnel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-Week Study to Evaluate the Safety of a Probiotic Water Containing Streptococcus Salivarius DB-B5 in Healthy Volunteer Subjects
The purpose of this study is to evaluate the safety of an oral probiotic in healthy individuals.
Read the detailed description
The oral cavity houses one of the most diverse microbiota in the human body. There are nearly 800 unique oral bacterial species identified with more species expected to be added with further sampling and identification. As with microbiota of other sites in the human body, a balanced oral microbiota is essential to maintaining the health of the human host. Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from birth, and remains a predominant member of the commensal microbiota throughout life. This randomized, double-blind, placebo-controlled study is conducted to investigate the safety and tolerability of a Streptococcus salivarius DB-B5 strain.
- Conditions
- Healthy Adults
- Being tested
- Streptococcus salivarius DB-B5, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptococcus salivarius DB-B5Dietary supplement
Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.
PlaceboOther
Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Powdered probiotic with a carrier. Receives: Dietary Supplement: Streptococcus salivarius DB-B5 |
| Placebo | Placebo comparator | Carrier only. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reports of adverse events
Reports of adverse events will be collected and compared between the probiotic and placebo groups.
Measured: 4 weeks
Change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal tolerability to the test products will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is composed of 15 items covering 5 dimensions: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: 4 weeks
Occurrence of abnormal blood laboratory test results
Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in hematology parameters (complete blood count including differentials and platelets).
Measured: 4 weeks
Occurrence of abnormal clinical chemistry parameters test results
Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in clinical chemistry parameters (basic metabolic panel, hepatic function panel).
Measured: 4 weeks
Occurrence of abnormal urinalysis test results
Urine samples will be collected at baseline and end-of-study visits to assess for changes in standard urinalysis parameters (specific gravity, pH, ketones, glucose, blood, bilirubin, and leukocyte esterase).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start28 Jul 2020
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dose Biosystems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Casser, M.D., Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492631
- Sponsor's protocol ID
- P1940120
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Fields FR, Ho M, Marshall-Hudson A, Gross R, Casser ME, Naito M. Safety assessment of Streptococcus salivarius DB-B5 as a probiotic candidate for oral health. Food Chem Toxicol. 2021 Jul;153:112277. doi: 10.1016/j.fct.2021.112277. Epub 2021 May 15.
PubMed 34004226
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week Study to Evaluate the Safety of a Probiotic Water Containing Streptococcus Salivarius DB-B5 in Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT04492631
- Acronym / sponsor ID
- P1940120
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dose Biosystems Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 30 Jul 2020 (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 purpose of this study is to evaluate the safety of an oral probiotic in healthy individuals.
Detailed description
The oral cavity houses one of the most diverse microbiota in the human body. There are nearly 800 unique oral bacterial species identified with more species expected to be added with further sampling and identification. As with microbiota of other sites in the human body, a balanced oral microbiota is essential to maintaining the health of the human host. Streptococcus salivarius is a pioneer species that colonizes the human oral cavity from birth, and remains a predominant member of the commensal microbiota throughout life. This randomized, double-blind, placebo-controlled study is conducted to investigate the safety and tolerability of a Streptococcus salivarius DB-B5 strain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Streptococcus salivarius DB-B5Powdered probiotic with a carrier. |
| Placebo | Placebo comparator | Other: PlaceboCarrier only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are adults, 18 to 65 years of age and in good general health and good oral health (no active or uncontrolled diseases or conditions);
- Have a body mass index (BMI) range of 18.5 - 35 kg/m^2;
- Have no known food allergies or intolerances;
- Have normal or acceptable to the Investigator vital signs (blood pressure, heart rate, respiratory rate, temperature) at screening and Day -1 and normal laboratory values and physical exam findings at screening;
- Agree not to make any major changes to their diet during the study;
Key exclusion criteria (13 listed)
- Have self-reported history of active or chronic dental or medical disease;
- Are prone to gas, bloating, or diarrhea;
- Have received antibiotic treatment in the three months prior to Day 1 or are unwilling to refrain from antibiotic use during the study;
- Used probiotic supplements or consumed probiotic rich foods such as yogurt or kefir within 30 days prior to Day 1 or are unwilling to refrain from the use of probiotic supplements or probiotic rich foods for the duration of the study, even if they are for non-oral health reasons (e.g., vaginal or gut health probiotics);
- Are pregnant, planning to become pregnant during the study period, or are breastfeeding a child;
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 |
|---|---|---|
| Streptococcus salivarius DB-B5Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day. | Dietary supplement | Probiotic |
| PlaceboSachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. | Other | Placebo |
Primary outcome
Reports of adverse events
Time frame: 4 weeks
Reports of adverse events will be collected and compared between the probiotic and placebo groups.
Change in gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 4 weeks
Gastrointestinal tolerability to the test products will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is composed of 15 items covering 5 dimensions: Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Occurrence of abnormal blood laboratory test results
Time frame: 4 weeks
Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in hematology parameters (complete blood count including differentials and platelets).
Occurrence of abnormal clinical chemistry parameters test results
Time frame: 4 weeks
Fasting blood samples will be collected at baseline and end-of-study visits to assess for changes in clinical chemistry parameters (basic metabolic panel, hepatic function panel).
Occurrence of abnormal urinalysis test results
Time frame: 4 weeks
Urine samples will be collected at baseline and end-of-study visits to assess for changes in standard urinalysis parameters (specific gravity, pH, ketones, glucose, blood, bilirubin, and leukocyte esterase).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 34004226Li X, Fields FR, Ho M, Marshall-Hudson A, Gross R, Casser ME, Naito M. Safety assessment of Streptococcus salivarius DB-B5 as a probiotic candidate for oral health. Food Chem Toxicol. 2021 Jul;153:112277. doi: 10.1016/j.fct.2021.112277. Epub 2021 May 15.
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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. This study is not recruiting at the moment.
Michael Casser, M.D. principal investigator
TKL Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streptococcus salivarius DB-B5 in people with Healthy Adults, run by Dose Biosystems Inc. at 1 site in United States.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 19 Oct 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reports of adverse events (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492631, which also lists 1 linked publication.
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 19 Oct 2020.