Spontaneous AbortionNCT07246486
Composition of the Intestinal Microbiome in Patients With Recurrent Spontaneous Abortions.
An observational study of Spontaneous Abortion, run by Dr. Natascha Köstlin-Gille at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Spontaneous Abortion
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Study population: non-pregnant women between 18 and 40 years
Who may be able to join
- Patient of the fertility center of the university hospital Tübingen
- 2 or 3 spontaneous abortions in medical history
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spontaneous Abortion
- Keywords
- microbiome, spontaneous abortion
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome
Microbiome Analysis from the stool samples
Measured: 48 month
Hormon levels
Hormone levels of Estrogen, Progesterone from blood and urine samples
Measured: 48 month
bacterial metabolic products
Metabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples
Measured: 48 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Nov 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Natascha Köstlin-Gille
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research
- Responsible party
- Sponsor-investigator, Dr. Natascha Köstlin-Gille, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246486
- Sponsor's protocol ID
- 730/2020BO2
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Composition of the Intesinal Microbiome in Women With Complication-free Pregnancy and Women With Recurrent Spontaneous Abortions.
- ClinicalTrials.gov ID
- NCT07246486
- Acronym / sponsor ID
- 730/2020BO2
- Conditions
- Spontaneous Abortion
- Keywords
- microbiome, spontaneous abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Natascha Köstlin-GilleUniversity, hospital or other
- Collaborators
- German Center for Infection Research
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- non-pregnant women between 18 and 40 years
Key inclusion criteria (2 listed)
- Patient of the fertility center of the university hospital Tübingen
- 2 or 3 spontaneous abortions in medical history
Key exclusion criteria (6 listed)
- Age under 18 years, age over 40 years
- Current pregnancy
- Immunosuppressive therapy
- Antibiotic therapy up to four weeks before admission
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intestinal microbiome
Time frame: 48 month
Microbiome Analysis from the stool samples
Hormon levels
Time frame: 48 month
Hormone levels of Estrogen, Progesterone from blood and urine samples
bacterial metabolic products
Time frame: 48 month
Metabolic products phytoestrogene enterodiol, enterolactone from blood and urine samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Abortion, run by Dr. Natascha Köstlin-Gille at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiome (time frame: 48 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.