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Completed

NCT Number: NCT07246486

Composition of the Intestinal Microbiome in Patients 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.

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Key information

Conditions

Spontaneous Abortion Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intestinal microbiome

    Time frame: 48 month

    Microbiome Analysis from the stool samples

  2. Hormon levels

    Time frame: 48 month

    Hormone levels of Estrogen, Progesterone from blood and urine samples

  3. bacterial metabolic products

    Time frame: 48 month

    Metabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples

Sponsors and collaborators

Lead sponsor

Dr. Natascha Köstlin-Gille

Other

Collaborators

  • German Center for Infection Research

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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