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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07246486
Enrollment
60
Registered
2025-11-24
Start date
2020-11-01
Completion date
2023-02-28
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Abortion

Keywords

microbiome, spontaneous abortion

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.

Detailed description

This study wants to investigate if there is a connection between the composition of the intestinal microbiome before pregnancy and the occurence of recurrent spontaneous abortions. Herefore samples of stool and blood serum will be sampled from patients with 2 or 3 consecutive spontaneous abortions and from patients with no abortions or premature birth and at least one pregnancy without complications. Microbiome analyses will be performed on the stool samples, the bloodserum will be used to analyze bacterial metabolic products. In this study 60 non-pregnant women will be included. 20 women with at least one complication-free pregnancy and no abortions or premature birth in medical history and 40 non-pregnant women with two or three recurrent spontaneous abortions in medical history.

Interventions

None listed

Sponsors

German Center for Infection Research
CollaboratorOTHER
Dr. Natascha Köstlin-Gille
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years

Inclusion criteria

* Patient of the fertility center of the university hospital Tübingen * 2 or 3 spontaneous abortions in medical history

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Intestinal microbiome48 monthMicrobiome Analysis from the stool samples
Hormon levels48 monthHormone levels of Estrogen, Progesterone from blood and urine samples
bacterial metabolic products48 monthMetabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026