Using synbiotics to reduce the risk of preterm birth
Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal
This study is testing if taking synbiotics can help women at high risk for preterm birth have healthier pregnancies by improving their vaginal microbiome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 9 sites (Edegem, Antwerpen and 8 other locations) |
| Trial ID | NCT05966649 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of synbiotics in women at high risk for preterm birth, particularly those with a history of spontaneous preterm delivery or other related complications. The study aims to assess whether synbiotics can positively influence the vaginal microbiome and potentially reduce the incidence of preterm labor. Participants will be randomly assigned to receive either synbiotics or a placebo, and their outcomes will be monitored throughout the pregnancy. The trial seeks to provide insights into the relationship between microbial colonization and preterm birth.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a singleton pregnancy who have a history of preterm birth or other risk factors for spontaneous preterm labor.
Not a fit: Patients with multiple pregnancies or those currently using pro-, pre-, or synbiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new preventive strategies for reducing the risk of preterm birth in high-risk women.
How similar studies have performed: While the use of synbiotics in pregnancy is an emerging area, previous studies have shown promising results in related fields, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem, Antwerpen and 8 other locations
- Universitaire Ziekenhuis Antwerpen — Edegem, Antwerpen, Belgium (Recruiting)
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Recruiting)
- Universitaire Ziekenhuizen Leuven — Leuven, Limburg, Belgium (Recruiting)
- CHR Citadelle — Liège, Liège, Belgium (Recruiting)
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- AZ Sint-Jan — Bruges, West-Vlaanderen, Belgium (Recruiting)
- AZ Sint-Lucas — Bruges, West-Vlaanderen, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, West-Vlaanderen, Belgium (Recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
Study contacts
- Study coordinator: Caroline Van Holsbeke, PhD
- Email: Caroline.van.holsbeke@zol.be
- Phone: 003289804057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.