CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
xylitol +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01528969
NCT01528969Phase 2Completed

The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts

Kuwait University·interventional·Posted Feb 8, 2012·Updated Aug 10, 2015

In Brief

A Phase 2 clinical trial evaluating xylitol and sorbitol for Bacterial Infections. Completed, enrolled 122 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKuwait

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2012
Enrollment StartMar 1, 2012
Primary CompletionApr 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.4 years ago

Interventions

xylitoldietary

Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period.

sorbitoldietary

Subjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period.