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

Dr. Natascha Köstlin-Gille

Status: Completed

Conditions: Spontaneous Abortion

Study type: Observational

Funder types: Other

Identifiers

NCT07246486

730/2020BO2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

2 spontaneous abortions

Description:

non-pregnant women with two spontaneous abortions in medical history

3 spontaneos abortions

Description:

non-pregnant women with two spontaneous abortions in medical history

controle-group

Description:

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