Composition of the Intestinal Microbiome in Patients With Recurrent Spontaneous Abortions.
The Composition of the Intesinal Microbiome in Women With Complication-free Pregnancy and Women With Recurrent Spontaneous Abortions.
1 other identifier
observational
60
1 country
1
Brief Summary
Up to 50% of all women suffer of a spontaneous abortion. Having two/three or more spontaneous abortions is one of the main reasons of unwanted childlessness. It is well known that the intestinal microbiome has many important roles in a healthy organism. Simultaneously, a dysbiosis can lead to diseases like, for example, chronic inflammatory bowel diseases, autoimmune diseases or diabetes. Several studies showed that there is a connection between a vaginal dysbiosis and premature birth or late abortion. It is still unclear what effects the composition of the intestinal microbiome before pregnancy has on the course of pregnancy. This study will be investigate if there is a connection between the composition of the intestinal microbiome and the occurence of recurrent spontaneous abortions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedFirst Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedNovember 24, 2025
November 1, 2020
2.3 years
November 17, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intestinal microbiome
Microbiome Analysis from the stool samples
48 month
Hormon levels
Hormone levels of Estrogen, Progesterone from blood and urine samples
48 month
bacterial metabolic products
Metabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples
48 month
Study Arms (3)
2 spontaneous abortions
non-pregnant women with two spontaneous abortions in medical history
3 spontaneos abortions
non-pregnant women with two spontaneous abortions in medical history
controle-group
non-pregnant women with at least one complication-free pregnancy with no premature birth or late abortion in medical history
Eligibility Criteria
non-pregnant women between 18 and 40 years
You may qualify if:
- Patient of the fertility center of the university hospital Tübingen
- or 3 spontaneous abortions in medical history
You may not qualify if:
- Age under 18 years, age over 40 years
- Current pregnancy
- Immunosuppressive therapy
- Antibiotic therapy up to four weeks before admission
- Acute infection
- Orale intake of probiotics up to four weeks before admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Natascha Köstlin-Gillelead
- German Center for Infection Researchcollaborator
Study Sites (1)
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Biospecimen
Stool samples for microbiome analyses Bloodserum and urine for hormone levels for bacterial metabolic products.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PD Dr. med. Natascha Köstlin-Gille
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 24, 2025
Study Start
November 1, 2020
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
November 24, 2025
Record last verified: 2020-11