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

November 17, 2025 updated by: Dr. Natascha Köstlin-Gille

The Composition of the Intesinal Microbiome in Women With Complication-free Pregnancy and Women With Recurrent Spontaneous Abortions.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • University Hospital Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

non-pregnant women between 18 and 40 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal microbiome
Time Frame: 48 month
Microbiome Analysis from the stool samples
48 month
Hormon levels
Time Frame: 48 month
Hormone levels of Estrogen, Progesterone from blood and urine samples
48 month
bacterial metabolic products
Time Frame: 48 month
Metabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples
48 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Natascha Köstlin-Gille

Collaborators

German Center for Infection Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 730/2020BO2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Abortion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe