Composition of the Intestinal Microbiome in Patients With Recurrent Spontaneous Abortions.

NCT ID: NCT07246486

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Spontaneous Abortion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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2 spontaneous abortions

non-pregnant women with two spontaneous abortions in medical history

No interventions assigned to this group

3 spontaneos abortions

non-pregnant women with two spontaneous abortions in medical history

No interventions assigned to this group

controle-group

non-pregnant women with at least one complication-free pregnancy with no premature birth or late abortion in medical history

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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German Center for Infection Research

OTHER

Sponsor Role collaborator

Dr. Natascha Köstlin-Gille

OTHER

Sponsor Role lead

Responsible Party

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Dr. Natascha Köstlin-Gille

PD Dr. med. Natascha Köstlin-Gille

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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730/2020BO2

Identifier Type: -

Identifier Source: org_study_id

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