Using synbiotics to reduce the risk of preterm birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Caroline Van Holsbeke, PhD
• Email: Caroline.van.holsbeke@zol.be
• Phone: 003289804057

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.