Phase 2 Completed N=75 Randomized Triple-blind Treatment

Effect of Xylitol on Oral Microbiota in Children

Bacterial Infections

Source: ClinicalTrials.gov NCT01528969 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2015

Primary outcomePrimary: MS Counts of Stimulated Saliva — 4.86; 4.40; 4.29; 3.78 MS counts log CFU/ml

Summary

1. The present controlled, randomized, doubleblind study aims to answer the following questions: * How will the "normal flora" be affected by the xylitol consumption? * Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci? * The association of the test results will also be compared with the caries status at the baseline. 2. About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group. 3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. 4. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.

Outcome Measures

Outcome	Result	p-value
PRIMARY MS Counts of Stimulated Saliva	4.86; 4.40; 4.29; 3.78	—
SECONDARY The Changes in the Counts of the 14 Other Bacterial Species	—	—

Eligibility Criteria

Inclusion Criteria

high SM count

Exclusion Criteria

low SM count,
ongoing medication

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Data sourced from ClinicalTrials.gov (NCT01528969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.