Heat-Inactivated Lactobacillus Salivarius HM-6 in Preschool Children With ECC

NCT07825324 | Completed

• 2 other identifiers: 1072.6120.31.2018N41/DBS/000164
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether a short, 14-day administration of chewable tablets containing heat-inactivated Lactobacillus salivarius HM-6 Paradens can influence selected salivary parameters related to oral health in preschool children. The probiotic preparation used in the intervention group is a commercially available product (Acidolac Dentifix Kids, Polpharma, Poland). Each tablet contains 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens, along with isomalt, sucralose, natural strawberry flavor, magnesium stearate, and 200 mg of xylitol. Children in the intervention group receive two chewable tablets per day for 14 consecutive days: one after breakfast and one at bedtime. Each tablet is taken after toothbrushing. After chewing the tablet, children are instructed not to eat or drink for two hours to ensure consistent exposure to the preparation. Adherence is monitored by counting unused tablets returned by caregivers. Missing no more than two tablets per week is considered acceptable adherence, while more frequent missed doses are classified as questionable compliance. Caregivers are asked to report any illnesses, adverse events, or circumstances that may influence the child's participation. Before the intervention, each child undergoes a dental examination. The presence of early childhood caries (ECC) is recorded, and caries severity is assessed using the International Caries Detection and Assessment System II (ICDAS II). Baseline ICDAS II scores are used to analyze whether initial caries severity affects changes in salivary parameters. Saliva samples are collected at two time points: before the intervention and after 14 days of follow-up. Collections take place between 8:00 AM and 10:00 AM. Caregivers ensure that children do not eat or drink (except water) for at least 60 minutes before sampling and do not perform oral hygiene beforehand. Unstimulated whole saliva is collected into sterile polypropylene tubes, refrigerated immediately, centrifuged to remove debris, aliquoted, and stored at -80°C. Stimulated saliva is collected using a Salivette kit (Sarstedt, Germany). Children chew a sterile swab for 2-3 minutes, after which the sample is centrifuged, aliquoted, and stored at -80°C. All samples undergo one freeze-thaw cycle before analysis. Salivary pH is measured at baseline and after the intervention under standardized preanalytical conditions. Results are reported as dimensionless pH values. The study procedures are non-invasive and well tolerated by children. The goal is to determine whether short-term exposure to an inactivated probiotic preparation can beneficially influence the oral environment and salivary biomarkers in preschool-aged children.

Conditions

Probiotic

Keywords

ECC; probiotics

Outcome Measures

Primary Outcomes (1)

• Change in salivary pH

  Unstimulated saliva pH measured between 8:00-10:00 AM under standardized preanalytical conditions.

  Baseline (Day 0) and Day 14

Secondary Outcomes (2)

• Change in salivary secretory IgA (sIgA)

  Baseline (Day 0) and Day 14

• Change in salivary human β-defensin 2 (hBD-2)

  Baseline (Day 0) and Day 14

Other Outcomes (1)

• Change in salivary FRAP (ferric reducing antioxidant power)

  Frame: Day 0 and Day 14

Study Arms (2)

Children in the intervention group received commercially available chewable tablets containing 10 mg

EXPERIMENTAL

Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens. The preparation also contained isomalt, sucralose, natural strawberry flavor, magnesium stearate, and xylitol at 200 mg per tablet (Acidolac Dentifix Kids, Polpharma, Poland).

Dietary Supplement: Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens.

control

NO INTERVENTION

Saliva samples were collected before the intervention and after 14 days of follow-up, between 8:00 AM and 10:00 AM. Parents and guardians were instructed to ensure that children did not consume any food or drink, except water, for at least 60 minutes prior to collection, and did not engage in oral hygiene. Unstimulated whole saliva was collected in sterile polypropylene tubes. Immediately after collection, samples were refrigerated and then centrifuged for 10 minutes at 4°C to remove cells, food debris, and other con-taminants. The resulting supernatant was divided into working aliquots and stored at -80°C until assayed. Samples underwent one freeze-thaw cycle. For stimulated saliva collection, a Salivette kit was used according to the manufac-turer's instructions (Sarstedt, Nümbrecht, Germany). The child chewed a sterile insert for approximately 2-3 minutes, after which it was placed in a dedicated tube using sterile forceps. Samples were centrifuged at 1000 × g for 5 minutes at 4°C.

Interventions

Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens. DIETARY_SUPPLEMENT

Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens. The preparation also contained isomalt, sucralose, natural strawberry flavor, magnesium stearate, and xylitol at 200 mg per tablet (Acidolac Dentifix Kids, Polpharma, Poland). The preparation was administered for 14 consecutive days at a dose of two tablets per day: one after breakfast and one at bedtime, each time after toothbrushing. After taking the tablet, participants were advised to refrain from eating and drinking for two hours. Adherence was assessed based on the number of unused tablets returned to the study team. Missing no more than two tablets per week was considered acceptable adherence to the protocol, while more frequent missed doses were classified as questionable compli-ance. Caregivers were also required to report adverse events, illnesses, and other cir-cumstances that might affect the study.

Children in the intervention group received commercially available chewable tablets containing 10 mg

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 3-6 years;
• generally good health;
• no use of antibiotics or probiotics in the three months preceding study entry;
• ability and willingness of the child to chew tablets and participate in study pro-cedures;
• obtaining written informed consent from a parent or legal guardian.

You may not qualify if:

• severe infections, systemic diseases, immune disorders, congenital defects
• food allergies
• active inflammatory diseases of the oral cavity, periodontal disease, and the presence of fixed orthodontic appliances
• the use of anti-inflammatory medications, glucocorticosteroids, probiotics, vitamin supplements, or other products that could affect the parameters assessed within three months of the study
• partial or complete refusal of a dental examination by the child or their guardian

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College in Krakow

Krakow, Małoposlka, 31-155, Poland

Location

Related Links

• Bioethical Comisiion Jagiellońian University Medical College in Krakow

Study Officials

• Małgorzata MS Staszczyk, PhD

  Department of Developmental Age Dentistry Jagiellonian University in Krakow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomised trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant,dentist,department of pediatric dentistry Jagiellonian University Medical College in Krakow

Model Details: Children in the intervention group received commercially available chewable tablets containing 10 mg of heat-inactivated Lactobacillus salivarius HM-6 Paradens. The preparation also contained isomalt, sucralose, natural strawberry flavor, magnesium stearate, and xylitol at 200 mg per tablet (Acidolac Dentifix Kids, Polpharma, Poland). The preparation was administered for 14 consecutive days at a dose of two tablets per day: one after breakfast and one at bedtime, each time after toothbrushing. After taking the tablet, participants were advised to refrain from eating and drinking for two hours. Adherence was assessed based on the number of unused tablets returned to the study team. Missing no more than two tablets per week was considered acceptable adherence to the protocol, while more frequent missed doses were classified as questionable compli-ance. Caregivers were also required to report adverse events, illnesses, and other cir-cumstances that might affect the study

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: September 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 28.08.2026-01.01.20217
• Access Criteria: who have acces to clinical trialswszyscy naukowcy

Locations

PL (1)