Synbiotics in Patients at RIsk fOr Preterm Birth

NCT ID: NCT05966649

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2028-06-30

Brief 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. 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.

Conditions

Preterm Spontaneous Labor With Preterm Delivery; Preterm Birth; Microbial Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Synbiotics

Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.

Group Type: EXPERIMENTAL

Synbiotics

Intervention Type: OTHER

Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo

Interventions

Synbiotics

Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.

Intervention Type: OTHER

Placebo

Matching placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status: RECRUITING

Universitaire Ziekenhuizen Leuven

Leuven, Limburg, Belgium

Site Status: RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Site Status: RECRUITING

AZ Sint-Jan

Bruges, West-Vlaanderen, Belgium

Site Status: RECRUITING

AZ Sint-Lucas

Bruges, West-Vlaanderen, Belgium

Site Status: RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status: RECRUITING

CHR Citadelle

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Caroline Van Holsbeke, PhD

Role: CONTACT

Caroline.van.holsbeke@zol.be

003289327521

Katrien Nulens, MD

Role: CONTACT

Katrien_Nulens@hotmail.com

003289327521

Facility Contacts

Els Papy, MSc

Role: primary

els.papy@zol.be

0032 89 32 75 30

Myrthe Hoeven, MSc

Role: backup

myrthe.hoeven@zol.be

0032 89 32 75 31

Ann-Julie Trippas

Role: primary

ann-julie.trippas@uzleuven.be

0032 16 34 64 51

Astrid Luypaert, PhD

Role: primary

gynobs.studies@uzgent.be

0032 9 332 07 58

Premilla Rousseau

Role: primary

Premila.Rousseau@azsintjan.be

Veerle De Prest

Role: primary

studies.gynaeco@stlucas.be

0032 50 36 51 04

Kim Demets

Role: primary

0032 56 63 32 40

Marie Timmermans

Role: primary

marie.timmermans@chuliege.be

0032 4 321 75 57

References

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.

Reference Type: DERIVED

PMID: 39289685 (View on PubMed)

Other Identifiers

Z-2022080

Identifier Type: -

Identifier Source: org_study_id