CompletedPhase 2

Probiotic Lactobacillus Reuteri and Oral Microbiota

44 participantsStarted 2013-03

Plain-language summary

In February 2013, 44 healthy adults was recruited and randomized to daily intake of lozenges with or without Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks. The effect of these Lactobacillus reuteri strains on the oral microbial composition was monitored before, after 4, 8 and 12 weeks and after 1 and 6 months after exposure was completed. For this purpose saliva and tooth plaque was collected. Of 44 included subjects, 41 completed the study. The used Lactobacillus reuteri containing lozenges are commercially available and identical placebo lozenges was obtained from the manufacturer. The study product was well tolerated with no observed side effects. Compliance was excellent. The investigators' primary outcome was to determine whether daily intake of Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks alters the tooth colonizing bacterial plaque composition determined by a multiplex sequencing technique. Effects are put in relation to general knowledge on bacterial profiles associated with risk to develop dental caries and periodontitis.

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult, * healthy, * no antibiotic treatment and no intake of probiotic products latest 3 months Exclusion Criteria: * Acute or chronic disease at recruitment, medication.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in oral bacteria biofilm composition after 12-week supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289

Timeframe: Baseline, after 4, 8 and 12 week treatment, and 1 and 6 months after treatment has terminated

Trial details

NCT IDNCT02311218

SponsorUmeå University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

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