NCT07308327

The Influence of Gut Microbiota on Ovarian Function: A Single-center, Randomized,Double Blind, Parallel-controlled, Exploratory Clinical Trial

Intestinal Probiotics Dietary Supplement

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Songling Zhang · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

In order to study the community profile of the intestinal microbiome in women with ovarian dysfunction, as well as the relationship between the changes in the intestinal microbiota and sex hormones, this study recruited 30 women with ovarian dysfunction and 30 healthy women. Sequencing was performed on the V3-V4 region of the 16S rDNA gene in fecal samples, and blood serum of the patients was collected for the study of changes in the systemic metabolome to reveal the significant differences in the intestinal microbiota between the subjects with ovarian dysfunction and the control group, as well as the related metabolic pathways.

Detailed description

At the same time, in order to evaluate the effectiveness, safety and tolerance of supplementing the Akk. muciniphila bacteria, as well as to explore the impact of supplementing Akk. muciniphila bacteria on human ovarian function, this study aims to be the first clinical research to explore the effect of supplementing Akk. muciniphila bacteria on human ovarian function.

Conditions

• Premature Ovarian Failure (POF)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Akk Gut Bacteria Supplement	Taking the Aakk intestinal bacteria supplement for three months
OTHER	Give a placebo	The appearance and smell of the placebo are the same as those of the active bacterial agent.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: China