Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Follicle stimulating hormone
研究概览
简要总结
The goal of this observational study is to investigate the distinct tongue manifestation characteristics in patients with diminished ovarian reserve (DOR) compared to healthy individuals, and to clarify the features of tongue coating microbiota, gut microbiota, and their interrelationships in DOR patients. The main question it aims to answer is:
Whether there are significant differences in tongue manifestations, tongue coating microbiota, and gut microbiota characteristics between DOR patients and healthy populations; Whether associations exist between tongue coating microbiota and gut microbiota in DOR patients; Whether the pathogenesis of DOR may influence estrogen metabolism through alterations in oral and gut microbiota.
详细描述
This study enrolled DOR patients and healthy women as controls to systematically analyze compositional differences in intestinal and tongue coating microbiota between the two groups. Using 16S rDNA sequencing technology combined with bioinformatics methods, we screened characteristic microbiota associated with DOR and identified microbial markers significantly correlated with serum estrogen levels (AMH, FSH) through Spearman correlation analysis. We further compared abundance differences of homologous bacteria between tongue coating and gut microbiota to determine whether DOR alters the abundance or prevalence of specific bacterial species by affecting tongue-gut axis microbial interactions. The potential of tongue-gut differential microbiota combinations as non-invasive diagnostic biomarkers for DOR was explored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged >20 years.
- •Diagnosis required meeting the essential criterion of AMH <1.1 ng/mL plus at least one supportive criterion: FSH >10 IU/L, FSH/LH ratio >3.0, or AFC <5-7 follicles (measured on menstrual days 2-3).
- •Conscious with intact cognitive/linguistic functions to comply with study protocols.
- •Approved by Ethics Committee of Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, with written informed consent obtained.
排除标准
- •Female participants aged <20 years.
- •Women in menopause, pregnancy, or lactation period.
- •Participants with comorbidities that may interfere with drug efficacy (e.g., severe chronic diseases).
- •Severe primary disorders involving cardiovascular, hepatic, renal, hematopoietic systems, or psychiatric illnesses.
- •Non-compliance with medication protocols during the study, or cases with undeterminable efficacy outcomes/incomplete data.
- •Use of sex hormone therapy within the past 3 months.
- •Diagnosis of reproductive system malignancies.
- •Gastrointestinal disorders or abnormal liver function.
- •Poor adherence to study protocols or lost to follow-up.
结局指标
主要结局
Follicle stimulating hormone
时间窗: On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.
Follicle stimulating hormone in IU/L
次要结局
- gut microbiota(Fresh fecal samples were collected in the morning under fasting conditions within one week after menstruation completion during the first menstrual cycle following enrollment.)
- anti-mullerian hormone(On the first day following participant enrollment.)
- Antral Follicle Counting(On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.)
- tongue coating microbiota(Tongue coating samples were collected in the morning under fasting conditions within one week after menstruation completion during the first menstrual cycle following enrollment, with priority given to coordinating collection on the same day as fecal spe)
- pregnancy outcome(1-year follow-up period post-detection)
研究者
Wenjun Xiao
gynecologist
Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University