Unexplained Recurrent Pregnancy Loss: New Therapeutic Perspectives

March 5, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

  • Italy
      • Rome, Italy, 00168
        • Reasearch Laboratory 3J IRCCS Gemelli

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Idiopathic recurrent pregnancy loss
  • Genetic predisposition to celiac disease

Exclusion Criteria:

-

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bifidobacterium Longum
Dietary supplement: Bifidobacterium Longum ES1
Oral administration of Bifidobacterium Longum ES1 for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Chiara Tersigni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

January 1, 2021

Primary Completion (Actual)

July 5, 2023

Study Completion (Estimated)

July 6, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1355

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.

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