A Phase 1/2 interventional study of xylitol and sorbitol in Bacterial Infections, sponsored by Kuwait University. Completed at 1 site in Kuwait. Open to male participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-10.
Sponsored by Kuwait University · Phase 1/2, Interventional, and Treatment
The present controlled, randomized, doubleblind study aims to answer the following questions:
Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.
The present controlled, randomized, doubleblind study aims to answer the following questions:
After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).
Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. 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. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 122 is above the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Kuwait University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A half of the subjects will be randomly allocated into xylitol group.
Dietary Supplement: xylitol
About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day
Dietary Supplement: sorbitol
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.
Also known as: Xylitol chewing gum, Sorbitol chewing gum
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.
Also known as: Sorbitol chewing gum
MS Counts of Stimulated Saliva
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Time frame: 5 weeks
The Changes in the Counts of the 14 Other Bacterial Species
The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Time frame: 5 weeks
Altogether 122 10-12-year-old boys, whose parents gave a positive consent, participated in the baseline examinations. The study was conducted at one school in Jabriya, Kuwait.
| Milestone | Xylitol | Sorbitol |
|---|---|---|
| Started | 37 | 38 |
| Completed | 35 | 38 |
| Not completed | 2 | 0 |
| Withdrew: Absent from the school at baseline | 2 | 0 |
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
| MS counts log CFU/ml | Xylitol | Sorbitol |
|---|---|---|
| Baseline | 4.86 ± 1.34 | 4.40 ± 1.71 |
| 5-week follow-up | 4.29 ± 1.73 | 3.78 ± 1.83 |
The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Results for this outcome have not been posted.
Collected over during the 1st week after the intervention was concluded.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xylitol | — | 0/35 (0%) | 0/35 (0%) |
| Sorbitol | — | 0/38 (0%) | 0/38 (0%) |
| Event | Xylitol | Sorbitol |
|---|---|---|
| DiarrheaGastrointestinal disorders | 0/35 | 0/38 |
| Age, Continuous(years) | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Mean | 11.5 (10 to 12) | 11.5 (10 to 12) | 11.5 (10 to 12) |
| Sex: Female, Male(Participants) | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 37 | 38 | 75 |
| Ethnicity (NIH/OMB)(Participants) | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 37 | 38 | 75 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 37 | 38 | 75 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Kuwait | 37 | 38 | 75 |
| Nationality of subjects(participants) | Xylitol | Sorbitol | Total |
|---|---|---|---|
| Kuwaiti | 36 | 37 | 73 |
| non-Kuwaiti Arab | 1 | 1 | 2 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Kuwait University