NCT07124260

Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve

Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diminished Ovarian Reserve

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	gut microbiota	Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing.
DIAGNOSTIC_TEST	tongue coating microbiota	Tongue coating samples were collected under fasting conditions between 6:00-9:00 AM on the same day as fecal specimen collection and subjected to 16S rDNA sequencing.
DIAGNOSTIC_TEST	tongue picture	Tongue images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection.

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2025-08-15
• Last updated: 2025-08-26

Locations

1 site across 1 country: China