Unexplained Recurrent Pregnancy Loss: New Therapeutic Perspectives

Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Miscarriage, Recurrent Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reasearch Laboratory 3J IRCCS Gemelli

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Idiopathic recurrent pregnancy loss
Genetic predisposition to celiac disease

Exclusion criteria

Treatment and study plan

Bifidobacterium Longum ES1

Dietary Supplement

Oral administration of Bifidobacterium Longum ES1 for three months.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2025
First posted: Mar 10, 2025
Registry last updated: Mar 10, 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.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting