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Could probiotics stop preterm birth? new trial investigates

NCT ID NCT05966649

Prevention Sponsor: Ziekenhuis Oost-Limburg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily oral synbiotic (a mix of probiotics and prebiotics) can help women with a history of preterm birth carry their baby longer. About 400 pregnant women will take either the supplement or a placebo from early pregnancy. The goal is to see if the supplement improves vaginal health and reduces the chance of delivering too early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral synbiotic (8 probiotic Lactobacillus strains, inulin, FOS, D-mannose)
What this could lead to
If it works, this could offer a simple, safe way to reduce the risk of preterm birth in women who have had one before.
What could go wrong
This is a mid-sized trial, and the effect may be small or not work for everyone. The supplement is generally safe, but results are not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 402 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed written informed consent must be obtained before any study assessment is performed; 2. 18 years of age or older; 3. Singleton pregnancy; 4. Pregnancy consultation between 8 and 10 weeks gestation. 5. At least one of the following risk factors for spontaneous preterm birth: * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency * PPROM ≤36 weeks in previous pregnancy * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks. Exclusion Criteria: 1. Patients who are already using pro-, pre- or synbiotics and not willing to stop 2. Multiple pregnancy 3. Need for primary (type 1) cerclage 4. Inflammatory bowel disease 5. Known congenital uterine anomaly 6. History of LLETZ conization

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Conditions

The condition(s) this trial relates to.

infectious disease Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Microbial colonization Microbiome dysbiosis Preterm birth Preterm spontaneous labor with preterm delivery Synbiotics Vaginal microbiome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Groeninge

    RECRUITING

    Kortrijk, 8500, Belgium

  • AZ Maria Middelares

    RECRUITING

    Ghent, West-Vlaanderen, 9000, Belgium

  • AZ Sint-Jan

    RECRUITING

    Bruges, West-Vlaanderen, 8300, Belgium

  • AZ Sint-Lucas

    RECRUITING

    Bruges, West-Vlaanderen, 8310, Belgium

  • CHR Citadelle

    RECRUITING

    Liège, Liège, 4000, Belgium

  • UZ Gent

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitaire Ziekenhuis Antwerpen

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Universitaire Ziekenhuizen Leuven

    RECRUITING

    Leuven, Limburg, 3000, Belgium

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, Limburg, 3600, Belgium

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