A Multi-Center Open-label Interventional Pilot Clinical Study to Evaluate the Effectiveness of a Nutraceutical Formulation Containing Phosphatidylserine Probiotics Essential Oils and DHA in Improving Oral Microbiota and Overall Oral Health in Children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
- 试验地点
- 3
- 主要终点
- Reduction in Streptococcus mutans and Lactobacillus acidophilus levels from baseline to Week 6.
研究概览
简要总结
This is a Pilot, open-label, multi-center, interventional clinical trial designed to evaluate the effectiveness of a nutraceutical formulation in improving oral microbiota balance and overall oral health in children aged 5 to 14 years. A total of 225 participants will be enrolled across three clinical sites. Subjects will receive a fixed dose of two functional probiotic-based candies per day for 42 days. The primary endpoint is the reduction in Streptococcus mutans and Lactobacillus acidophilus levels, assessed through agar culture methodology. Secondary endpoints include improvements in gingival health, reduction in halitosis, and evaluation of product safety and tolerability. The study aims to generate preliminary efficacy and safety data for this formulation as a supportive oral health supplement for pediatric use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects aged 5–14 years.
- •No history of severe periodontal disease, recurrent oral infections, or advanced dental caries requiring medical intervention.
- •No use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days prior to study enrollment.
- •Willing to maintain regular oral hygiene practices during the study.
排除标准
- •History of severe oral disease requiring medical intervention.
- •Use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days before screening.
- •Pregnant or lactating women.
- •Known allergy to any ingredient in the Nutraceutical Formulation.
- •Diagnosed gastrointestinal disorders that may interfere with probiotic absorption.
- •Individuals currently enrolled in another clinical trial.
结局指标
主要结局
Reduction in Streptococcus mutans and Lactobacillus acidophilus levels from baseline to Week 6.
时间窗: At Week 6 Last microbiota sampling will be done i.e at 3rd follow up
次要结局
- To evaluate the reduction in halitosis over 6 weeks using a questionnaire. (based on the perception of the subject).
- To measure improvements in gingival health as assessed by Gingival Index scores.(At Week 6 gingival scores will be taken again i.e at 3rd follow up)
- To analyze microbial balance shifts that reduce harmful bacterial strains like Streptococcus mutans and Lactobacillus acidophilus(At Week 6 Last microbiota sampling will be done i.e at 3rd follow up)