Phase 2
N=75
Effect of Xylitol on Oral Microbiota in Children
Bacterial Infections
Bottom Line
View on ClinicalTrials.gov: NCT01528969 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: MS Counts of Stimulated Saliva — 4.86; 4.40; 4.29; 3.78 MS counts log CFU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- xylitol (Dietary_supplement); sorbitol (Dietary_supplement)
- Age
- Pediatric · 11+ yrs
- Sex
- Male
- Sponsor
- Kuwait University
- Primary completion
- Apr 2012
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 |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- high SM count
Exclusion Criteria
- low SM count,
- ongoing medication
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.