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Research on Probiotics for Improving Early Childhood Caries (ECC) in Children.

Research on Probiotics for Improving Early Childhood Caries (ECC) in Children.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092615
Enrollment
Unknown
Registered
2024-11-20
Start date
2024-08-07
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Caries

Interventions

Probiotic Group: Probiotics
Placebo Group:Placebo without Probiotics

Sponsors

Wuxi Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: The experimental process adheres to the relevant rules, with children aged 3-6 years old; 1. All primary teeth have erupted; 2. No antibiotics or other antimicrobial drugs that could alter the oral flora have been used in the last month, nor have products containing probiotics; 3. No fluoride toothpaste has been used or fluoride treatments received in the last month; 4. Apart from dental caries, there are no other oral diseases or systemic diseases; 5. The number of decayed, missing, and filled teeth (DMFT) in children with ECC is >=6. The lifestyle remains unchanged and the children are in good health during the study period.

Exclusion criteria

Exclusion criteria: 1. Unable to attend follow-up visits within the specified time or explicitly express the intention to withdraw from the experiment, 2. The use of antibiotics during the intervention and washout period due to necessity, or the consumption of yogurt containing probiotics. Before recruiting volunteers, the doctors will explain the study content in detail to the guardians of the volunteers, obtain their consent, and have the guardians sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
oral microbiome changes;Streptococcus mutans levels;Candida albicans levels;

Countries

China

Contacts

Public ContactXu Xianyin

Wuxi Children's Hospital

imaginal_line@sina.com+86 133 0617 8180

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026