Synbiotics in Patients at RIsk fOr Preterm Birth

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Communicable Diseases
Infections
Microbial Colonization
Premature Birth
Preterm Birth
Preterm Spontaneous Labor With Preterm Delivery

Clinical Trial Details

NCT number	NCT05966649
Study type	Interventional
Source	Ziekenhuis Oost-Limburg
Contact	Caroline Van Holsbeke, PhD
Phone	003289327521
Email	Caroline.van.holsbeke@zol.be
Status	Recruiting
Phase	N/A
Start date	March 16, 2023
Completion date	June 2028

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Completed	`NCT05502510` - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Completed	`NCT02993744` - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone	N/A
Active, not recruiting	`NCT02673216` - Infection and Adverse Pregnancy Outcome
Completed	`NCT01683565` - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood	Phase 4
Completed	`NCT01412931` - Protein and Ultrasound Indicators of Preterm Birth	N/A
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT02606058` - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?	N/A
Terminated	`NCT03715530` - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women	N/A
Completed	`NCT00422526` - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial	Phase 3
Enrolling by invitation	`NCT04251260` - Effectiveness of Positioning in Preterm Neonates	N/A
Completed	`NCT03668860` - India Dexamethasone and Betamethasone	Phase 1
Recruiting	`NCT03638037` - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed	`NCT02225353` - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery	Phase 2
Recruiting	`NCT03992534` - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth	Phase 1
Completed	`NCT03144141` - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery	N/A
Completed	`NCT05210985` - Examination of the Relationship Between Home Affordances With Development
Completed	`NCT04811742` - Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Synbiotics in Patients at RIsk fOr Preterm Birth — PRIORI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms