Miscarriage, RecurrentNCT06867900
Unexplained Recurrent Pregnancy Loss: New Therapeutic Perspectives
A study testing Bifidobacterium Longum ES1 in people with Miscarriage, Recurrent, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage, Recurrent
- What is being tested?
- Bifidobacterium Longum ES1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 6 Jul 2025
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic recurrent pregnancy loss
- Genetic predisposition to celiac disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1.
- Conditions
- Miscarriage, Recurrent
- Being tested
- Bifidobacterium Longum ES1
- Keywords
- Recurrent pregnancy loss
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium Longum ES1Dietary supplement
Oral administration of Bifidobacterium Longum ES1 for three months.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium Longum | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium Longum ES1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Endometrial inflammation in RPL women
Analysis of the inflammasome NALP3 expression and activation in serum and endometrial fluid in women with unexplained recurrent pregnancy loss compared to women with uncomplicated pregnancy history.
Measured: 3 months
Assessment of Gut permeability status in RPL women
Analysis of zonulin expression and activation in serum and endometrial fluid in women with unexplained recurrent pregnancy loss compared to women with uncomplicated pregnancy history.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jan 2021
- Primary completion5 Jul 2023
- Study completion6 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage, RecurrentStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Tersigni, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867900
- Sponsor's protocol ID
- 1355
- Status last verified
- Sep 2024
- First submitted
- 6 Jul 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexplained Recurrent Pregnancy Loss: New Therapeutic Perspectives
- ClinicalTrials.gov ID
- NCT06867900
- Acronym / sponsor ID
- 1355
- Conditions
- Miscarriage, Recurrent
- Keywords
- Recurrent pregnancy loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 6 Jul 2025 (estimated)
- First posted
- 10 Mar 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.
Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium Longum | Experimental | Dietary Supplement: Bifidobacterium Longum ES1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic recurrent pregnancy loss
- Genetic predisposition to celiac disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium Longum ES1Oral administration of Bifidobacterium Longum ES1 for three months. | Dietary supplement | Bifidobacterium Longum |
Primary outcome
Assessment of Endometrial inflammation in RPL women
Time frame: 3 months
Analysis of the inflammasome NALP3 expression and activation in serum and endometrial fluid in women with unexplained recurrent pregnancy loss compared to women with uncomplicated pregnancy history.
Assessment of Gut permeability status in RPL women
Time frame: 3 months
Analysis of zonulin expression and activation in serum and endometrial fluid in women with unexplained recurrent pregnancy loss compared to women with uncomplicated pregnancy history.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
Chiara Tersigni principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium Longum ES1 in people with Miscarriage, Recurrent, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 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 Italy. 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?
Results are not available in the source record.
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?
Assessment of Endometrial inflammation in RPL women (time frame: 3 months). The study lists 2 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 10 Mar 2025.