NCT06867900

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2025

Completed
Last Updated

March 10, 2025

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

July 6, 2023

Last Update Submit

March 5, 2025

Conditions

Miscarriage, Recurrent

Keywords

Recurrent pregnancy loss

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Study Arms (1)

Bifidobacterium Longum

EXPERIMENTAL
Dietary Supplement: Bifidobacterium Longum ES1

Interventions

Bifidobacterium Longum ES1DIETARY_SUPPLEMENT

Oral administration of Bifidobacterium Longum ES1 for three months.

Bifidobacterium Longum

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic recurrent pregnancy loss
  • Genetic predisposition to celiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reasearch Laboratory 3J IRCCS Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Chiara Tersigni

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

March 10, 2025

Study Start

January 1, 2021

Primary Completion

July 5, 2023

Study Completion

July 6, 2025

Last Updated

March 10, 2025

Record last verified: 2024-09

Locations

IT(1)