---
title: Effect of Xylitol on Oral Microbiota in Children
nct_id: NCT01528969
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Kuwait University
study_type: INTERVENTIONAL
primary_condition: Bacterial Infections
countries: Kuwait
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01528969.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01528969"
ct_last_update_post_date: 2015-08-10
last_seen_at: "2026-05-12T07:05:24.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Xylitol on Oral Microbiota in Children

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

**NCT ID:** [NCT01528969](https://clinicaltrials.gov/study/NCT01528969)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 122
- **Lead Sponsor:** Kuwait University
- **Collaborators:** University of Turku, University of Michigan
- **Conditions:** Bacterial Infections
- **Start Date:** 2012-03
- **Completion Date:** 2012-05
- **CT.gov Last Update:** 2015-08-10

## Brief 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.

## Detailed Description

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:

1. How will the "normal flora" be affected by the xylitol consumption?
2. Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
3. The association of the test results will also be compared with the caries status at the baseline.

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.

## Eligibility

- **Minimum age:** 11 Years
- **Maximum age:** 14 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* high SM count

Exclusion Criteria:

* low SM count,
* ongoing medication
```

## Arms

- **Xylitol** (EXPERIMENTAL) — A half of the subjects will be randomly allocated into xylitol group.
- **Sorbitol** (ACTIVE_COMPARATOR) — About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day

## Interventions

- **xylitol** (DIETARY_SUPPLEMENT) — 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.
- **sorbitol** (DIETARY_SUPPLEMENT) — 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.

## Primary Outcomes

- **MS Counts of Stimulated Saliva** _(time frame: 5 weeks)_ — The MS counts were measured at the beginning and in the end of the 5 weeks intervention

## Secondary Outcomes

- **The Changes in the Counts of the 14 Other Bacterial Species** _(time frame: 5 weeks)_

## Locations (1)

- Faculty of Dentistry, Kuwait University, Kuwait City, Kuwait

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `locations.faculty of dentistry, kuwait university|kuwait city||kuwait` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01528969.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01528969*  
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