Preterm Spontaneous Labor With Preterm DeliveryPRIORINCT05966649
Synbiotics in Patients at RIsk fOr Preterm Birth
A study testing Synbiotics in people with Preterm Spontaneous Labor With Preterm Delivery and Preterm Birth, run by Ziekenhuis Oost-Limburg at 9 sites in Belgium.
Trial summary
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. 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
- Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth, Microbial Colonization
- What is being tested?
- Synbiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 9 sitesBelgium
- Study dates
- 16 Mar 2023to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed written informed consent must be obtained before any study assessment is performed;
- 18 years of age or older;
- Singleton pregnancy;
- Pregnancy consultation between 8 and 10 weeks gestation.
- 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.
Who cannot join
- Patients who are already using pro-, pre- or synbiotics and not willing to stop
- Multiple pregnancy
- Need for primary (type 1) cerclage
- Inflammatory bowel disease
- Known congenital uterine anomaly
- History of LLETZ conization
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Belgium9 sites, 9 recruiting
- Recruiting
AZ Sint-Jan
Bruges, West-Vlaanderen, 8300
Hanna Van Horen, 0032 50 45 32 46, hanne.vanhoren@azsintjan.be
Joachim Van Keirsbilck
- Recruiting
AZ Sint-Lucas
Bruges, West-Vlaanderen, 8310
Veerle De Prest, 0032 50 36 51 04, studies.gynaeco@stlucas.be
Caroline Van Holsbeke, PhD
- Recruiting
Universitaire Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650
Laury Knollenburg, 0032 3 436 85 32, Laury.Knollenburg@uza.be
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Els Papy, MSc, 0032 89 80 40 57, studies.gynaecologie@zol.be
Myrthe Hoeven, MSc, 0032 89 80 40 58, studies.gynaecologie@zol.be
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Astrid Luypaert, PhD, 0032 9 332 07 58, gynobs.studies@uzgent.be
Isabelle Dehaene, PhD
- Recruiting
AZ Maria Middelares
Ghent, West-Vlaanderen, 9000
Jolien Lansens, 0032 9 246 18 54, Jolien.Lansens@mijnziekenhuis.be
- Recruiting
AZ Groeninge
Kortrijk, 8500
Kim Demets, 0032 56 63 32 40
Eva Simoens
- Recruiting
Universitaire Ziekenhuizen Leuven
Leuven, Limburg, 3000
Ellen Reynders, 0032 16 34 29 96, ellen.reynders@uzleuven.be
Roland Devlieger, PhD
- Recruiting
CHR Citadelle
Liège, Liège, 4000
Marie Timmermans, 0032 4 321 75 57, marie.timmermans@chuliege.be
Véronique Masson
About this study
Official title: Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.
Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.
Read more
Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).
Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.
- Conditions
- Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth, Microbial Colonization, Microbiome Dysbiosis, Vaginal Microbiome, Synbiotics
- Being tested
- Synbiotics, Placebo
- Keywords
- Preterm birth, Vaginal microbiome, Probiotics, Synbiotics
- Medical subject headings
- Premature Birth, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticsOther
Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Synbiotics | Experimental | Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose. Receives: Other: Synbiotics |
| Placebo | Placebo comparator | Matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery
Measured: Through study completion - at delivery
Secondary outcomes (19)
Incidence of PTB, defined as GA at delivery < 37 weeks
Measured: Through study completion - at delivery
Proportion of PTB in different categories
- of patients that deliver < 28 weeks: extreme PTB
- of patients that deliver from 28 until 37 weeks: very PTB
- of patients that deliver from 32 until 37 weeks: moderate to late PTB
Measured: Through study completion - at delivery
PPROM
Incidence
Measured: Up to 34 weeks from the date of randomization
PPROM
Gestational age at PPROM
Measured: Up to 34 weeks from the date of randomization
PPROM
Time to delivery
Measured: Up to 34 weeks from the date of randomization
Composition of the vaginal microbiome
The vaginal microbiome will be assessed throughout pregnancy at 4 well-defined stages of pregnancy (9, 20, 30 weeks and at delivery) and at admission at the MIC unit for preterm labor, PPROM or cervical insufficiency.
Measured: Assessed 3 times during the study period: at randomization, 11-13 weeks after randomization (at gestational age 19-21 weeks), and 21-23 weeks after randomization (29-31 weeks of gestation)
Incidence of neonatal admissions
Measured: Neonatal admission at a neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Duration of neonatal admissions
Measured: Neonatal admission at a neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Incidence of maternal admissions
Measured: Up to 34 weeks from the date of randomization
Duration of maternal admissions
Measured: Up to 34 weeks from the date of randomization
Quality Of Life during pregnancy and during neonatal admission at a neonatal intensive care unit
Using EQ5D questionnaire (5 questions and scale from 1 to 100)
Measured: Trough study completion, on average 1 year
Neonatal outcome: infectious parameters
Sepsis (early, late and culture negative), number of episodes (min 72 hours) of antibiotic treatment, duration of antibiotic treatment in days
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: bronchopulmonary dysplasia (BPD)
Proportion of each category (no, mild, moderate and severe)
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: intraventricular haemorrhage
Incidence
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: periventricular leukomalacia
Incidence
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: respiratory support
Need for respiratory support (CPAP: continuous positive airways pressure, non-invasive positive pressure ventilation or mechanical endotracheal ventilation) and the duration of respiratory support in days. Use and administration of surfactant
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: retinopathy
Incidence
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: neonatal morbidity
Incidence
Measured: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: birth weight
Measured: After the neonate is born
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start16 Mar 2023
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Spontaneous Labor With Preterm DeliveryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Federaal Kenniscentrum voor Gezondheidszorg, Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966649
- Sponsor's protocol ID
- Z-2022080
- Acronym
- PRIORI
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nulens K, Papy E, Tartaglia K, Dehaene I, Logghe H, Van Keirsbilck J, Chantraine F, Masson V, Simoens E, Gysemans W, Bruckers L, Lebeer S, Allonsius CN, Oerlemans E, Steensels D, Reynders M, Timmerman D, Devlieger R, Van Holsbeke C. Synbiotics in patients at risk for spontaneous preterm birth: protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI). Trials. 2024 Sep 17;25(1):615. doi: 10.1186/s13063-024-08444-8.
PubMed 39289685
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal
- ClinicalTrials.gov ID
- NCT05966649
- Acronym / sponsor ID
- PRIORI / Z-2022080
- Conditions
- Preterm Spontaneous Labor With Preterm Delivery, Preterm Birth, Microbial Colonization, Microbiome Dysbiosis, Vaginal Microbiome, Synbiotics
- Keywords
- Preterm birth, Vaginal microbiome, Probiotics, Synbiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Federaal Kenniscentrum voor Gezondheidszorg, Belgium
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 28 Jul 2023 (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.
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.
Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.
Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).
Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotics | Experimental | Other: SynbioticsOral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose. |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent must be obtained before any study assessment is performed;
- 18 years of age or older;
- Singleton pregnancy;
- Pregnancy consultation between 8 and 10 weeks gestation.
- At least one of the following risk factors for spontaneous preterm birth:
Key exclusion criteria (6 listed)
- Patients who are already using pro-, pre- or synbiotics and not willing to stop
- Multiple pregnancy
- Need for primary (type 1) cerclage
- Inflammatory bowel disease
- Known congenital uterine anomaly
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 |
|---|---|---|
| SynbioticsOral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose. | Other | Synbiotics |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
Gestational age at delivery
Time frame: Through study completion - at delivery
19 secondary outcomes
Incidence of PTB, defined as GA at delivery < 37 weeks
Time frame: Through study completion - at delivery
Proportion of PTB in different categories
Time frame: Through study completion - at delivery
PPROM
Time frame: Up to 34 weeks from the date of randomization
PPROM
Time frame: Up to 34 weeks from the date of randomization
PPROM
Time frame: Up to 34 weeks from the date of randomization
Composition of the vaginal microbiome
Time frame: Assessed 3 times during the study period: at randomization, 11-13 weeks after randomization (at gestational age 19-21 weeks), and 21-23 weeks after randomization (29-31 weeks of gestation)
Incidence of neonatal admissions
Time frame: Neonatal admission at a neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Duration of neonatal admissions
Time frame: Neonatal admission at a neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Incidence of maternal admissions
Time frame: Up to 34 weeks from the date of randomization
Duration of maternal admissions
Time frame: Up to 34 weeks from the date of randomization
Quality Of Life during pregnancy and during neonatal admission at a neonatal intensive care unit
Time frame: Trough study completion, on average 1 year
Neonatal outcome: infectious parameters
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: bronchopulmonary dysplasia (BPD)
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: intraventricular haemorrhage
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: periventricular leukomalacia
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: respiratory support
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: retinopathy
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: neonatal morbidity
Time frame: During the admission at the neonatal intensive care unit (when the neonate is admitted at a neonatal intensive care unit within 7 days of delivery)
Neonatal outcome: birth weight
Time frame: After the neonate is born
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 39289685Nulens K, Papy E, Tartaglia K, Dehaene I, Logghe H, Van Keirsbilck J, Chantraine F, Masson V, Simoens E, Gysemans W, Bruckers L, Lebeer S, Allonsius CN, Oerlemans E, Steensels D, Reynders M, Timmerman D, Devlieger R, Van Holsbeke C. Synbiotics in patients at risk for spontaneous preterm birth: protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI). Trials. 2024 Sep 17;25(1):615. doi: 10.1186/s13063-024-08444-8.
- Individual participant dataSharing planned: Undecided
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotics in people with Preterm Spontaneous Labor With Preterm Delivery and Preterm Birth, run by Ziekenhuis Oost-Limburg at 9 sites in Belgium.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Van Holsbeke, PhD (003289804057, Caroline.van.holsbeke@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at delivery (time frame: Through study completion - at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966649, which also lists 1 linked publication.
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 27 Feb 2026.