xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966649</url>
    </required_header>
    <id_info>
      <org_study_id>Z-2022080</org_study_id>
      <nct_id>NCT05966649</nct_id>
    </id_info>
    <brief_title>Synbiotics in Patients at RIsk fOr Preterm Birth</brief_title>
    <acronym>PRIORI</acronym>
    <official_title>Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ziekenhuis Oost-Limburg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ziekenhuis Oost-Limburg</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prematurity remains the main cause of death and serious health problems in new-borns. Besides&#xD;
        the need for hospitalization and medical interventions in the first weeks or months of the&#xD;
        new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital&#xD;
        admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems,&#xD;
        ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the&#xD;
        medical problems and the financial cost, the emotional stress and psychological impact on the&#xD;
        parents, siblings and other family members should not be underestimated.&#xD;
  &#xD;
        Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent&#xD;
        preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as&#xD;
        'high risk' for preterm birth.&#xD;
  &#xD;
        Infections ascending from the vagina may be an important cause of preterm delivery in certain&#xD;
        cases. Some women have an abnormal vaginal microbiome and are therefore at risk for&#xD;
        infections and preterm birth. On the other hand, the vaginal flora is more stable and&#xD;
        resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of&#xD;
        gestation).&#xD;
  &#xD;
        Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria&#xD;
        with potential beneficial effects that can be used safely in pregnancy, while prebiotics are&#xD;
        consumed by the bacteria. It is known that probiotics, when used for a long period of time,&#xD;
        can maintain a healthy and stable vaginal flora that may protect against infections. In this&#xD;
        study, pregnant patients with a history of preterm birth will be included in the first&#xD;
        trimester of pregnancy to start with synbiotics or placebo. The investigators will examine&#xD;
        the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis&#xD;
        is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal&#xD;
        flora into a stable micro-environment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 16, 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gestational age at delivery</measure>
      <time_frame>Through study completion - at delivery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of PTB, defined as GA at delivery &lt; 37 weeks</measure>
      <time_frame>Through study completion - at delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of PTB in different categories</measure>
      <time_frame>Through study completion - at delivery</time_frame>
      <description>of patients that deliver &lt; 28 weeks: extreme PTB&#xD;
  of patients that deliver from 28 until 37 weeks: very PTB&#xD;
  of patients that deliver from 32 until 37 weeks: moderate to late PTB</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PPROM</measure>
      <time_frame>Up to 34 weeks from the date of randomization</time_frame>
      <description>Incidence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PPROM</measure>
      <time_frame>Up to 34 weeks from the date of randomization</time_frame>
      <description>Gestational age at PPROM</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PPROM</measure>
      <time_frame>Up to 34 weeks from the date of randomization</time_frame>
      <description>Time to delivery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Composition of the vaginal microbiome</measure>
      <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)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of neonatal admissions</measure>
      <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)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of neonatal admissions</measure>
      <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)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of maternal admissions</measure>
      <time_frame>Up to 34 weeks from the date of randomization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of maternal admissions</measure>
      <time_frame>Up to 34 weeks from the date of randomization</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality Of Life during pregnancy and during neonatal admission at a neonatal intensive care unit</measure>
      <time_frame>Trough study completion, on avarage 1 year</time_frame>
      <description>Using EQ5D questionnaire (5 questions and scale from 1 to 100)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: infectious parameters</measure>
      <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)</time_frame>
      <description>Sepsis (early, late and culture negative), number of episodes (min 72 hours) of antibiotic treatment, duration of antibiotic treatment in days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: bronchopulmonary dysplasia (BPD)</measure>
      <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)</time_frame>
      <description>Proportion of each category (no, mild, moderate and severe)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: intraventricular haemorrhage</measure>
      <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)</time_frame>
      <description>Incidence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: periventricular leukomalacia</measure>
      <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)</time_frame>
      <description>Incidence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: respiratory support</measure>
      <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)</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: retinopathy</measure>
      <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)</time_frame>
      <description>Incidence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: neonatal morbidity</measure>
      <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)</time_frame>
      <description>Incidence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal outcome: birth weight</measure>
      <time_frame>After the neonate is born</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Effect of antibiotics on the vaginal microbiome</measure>
      <time_frame>During pregnancy until 28 days after PPROM</time_frame>
      <description>When the patient is admitted in case the pregnancy was complicated with PPROM</description>
    </other_outcome>
    <other_outcome>
      <measure>Effect on the gastrointestinal microbiome of the neonate in case of PPROM</measure>
      <time_frame>Between 13 to 36 weeks from the date of randomization</time_frame>
      <description>When the neonate is born after a pregnancy complicated with PPROM</description>
    </other_outcome>
    <other_outcome>
      <measure>Placental microbiome in case of preterm birth</measure>
      <time_frame>Between 13 to 36 weeks from the date of randomization</time_frame>
      <description>In case the pregnancy was complicated with preterm birth (delivery before 37 weeks of gestation)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">402</enrollment>
    <condition>Preterm Spontaneous Labor With Preterm Delivery</condition>
    <condition>Preterm Birth</condition>
    <condition>Microbial Colonization</condition>
    <arm_group>
      <arm_group_label>Synbiotics</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Matching placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Synbiotics</intervention_name>
      <description>Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.</description>
      <arm_group_label>Synbiotics</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed written informed consent must be obtained before any study assessment is&#xD;
               performed;&#xD;
  &#xD;
            2. 18 years of age or older;&#xD;
  &#xD;
            3. Singleton pregnancy;&#xD;
  &#xD;
            4. Pregnancy consultation between 8 and 10 weeks gestation.&#xD;
  &#xD;
            5. At least one of the following risk factors for spontaneous preterm birth:&#xD;
  &#xD;
                 -  Prior spontaneous preterm birth, defined as delivery between 24 and 37 weeks&#xD;
                    following PPROM, preterm labor or cervical insufficiency&#xD;
  &#xD;
                 -  PPROM ≤37 weeks in previous pregnancy but delivery ≥37 weeks&#xD;
  &#xD;
                 -  Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm&#xD;
                    labor or cervical insufficiency with birth between 14 and 24 weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who are already using pro-, pre- or synbiotics&#xD;
  &#xD;
            2. Multiple pregnancy&#xD;
  &#xD;
            3. Need for primary (type 1) cerclage&#xD;
  &#xD;
            4. Inflammatory bowel disease&#xD;
  &#xD;
            5. Known congenital uterine anomaly&#xD;
  &#xD;
            6. History of LLETZ conization&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Caroline Van Holsbeke, PhD</last_name>
      <phone>003289327521</phone>
      <email>Caroline.van.holsbeke@zol.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katrien Nulens, MD</last_name>
      <phone>003289327521</phone>
      <email>Katrien_Nulens@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ziekenhuis Oost-Limburg</name>
        <address>
          <city>Genk</city>
          <state>Limburg</state>
          <zip>3600</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Els Papy, MSc</last_name>
        <phone>0032 89 32 75 30</phone>
        <email>els.papy@zol.be</email>
      </contact>
      <contact_backup>
        <last_name>Myrthe Hoeven, MSc</last_name>
        <phone>0032 89 32 75 31</phone>
        <email>myrthe.hoeven@zol.be</email>
      </contact_backup>
      <investigator>
        <last_name>Caroline Van Holsbeke, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Universitaire Ziekenhuizen Leuven</name>
        <address>
          <city>Leuven</city>
          <state>Limburg</state>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ann-Julie Trippas</last_name>
        <phone>0032 16 34 64 51</phone>
        <email>ann-julie.trippas@uzleuven.be</email>
      </contact>
      <investigator>
        <last_name>Roland Devlieger, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>UZ Gent</name>
        <address>
          <city>Gent</city>
          <state>Oost-Vlaanderen</state>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Astrid Luypaert, PhD</last_name>
        <phone>0032 9 332 07 58</phone>
        <email>gynobs.studies@uzgent.be</email>
      </contact>
      <investigator>
        <last_name>Isabelle Dehaene, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AZ Sint-Jan</name>
        <address>
          <city>Brugge</city>
          <state>West-Vlaanderen</state>
          <zip>8300</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Premilla Rousseau</last_name>
        <email>Premila.Rousseau@azsintjan.be</email>
      </contact>
      <investigator>
        <last_name>Joachim Van Keirsbilck</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>AZ Sint-Lucas</name>
        <address>
          <city>Brugge</city>
          <state>West-Vlaanderen</state>
          <zip>8310</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Veerle De Prest</last_name>
        <phone>0032 50 36 51 04</phone>
        <email>studies.gynaeco@stlucas.be</email>
      </contact>
      <investigator>
        <last_name>Caroline Van Holsbeke, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHR Citadelle</name>
        <address>
          <city>Liège</city>
          <zip>4000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marie Timmermans</last_name>
        <phone>0032 4 321 75 57</phone>
        <email>marie.timmermans@chuliege.be</email>
      </contact>
      <investigator>
        <last_name>Véronique Masson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>March 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Preterm birth</keyword>
    <keyword>Vaginal microbiome</keyword>
    <keyword>Probiotics</keyword>
    <keyword>Synbiotics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Premature Birth</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966649
  org study id: Z-2022080
  nct id: NCT05966649
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Gestational age at delivery
  time frame: Through study completion - at delivery
  measure: Incidence of PTB, defined as GA at delivery < 37 weeks
  time frame: Through study completion - at delivery
  measure: Proportion of PTB in different categories
  time frame: Through study completion - at delivery
  description: 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
  measure: PPROM
  time frame: Up to 34 weeks from the date of randomization
  description: Incidence
  measure: PPROM
  time frame: Up to 34 weeks from the date of randomization
  description: Gestational age at PPROM
  measure: PPROM
  time frame: Up to 34 weeks from the date of randomization
  description: Time to delivery
  measure: 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)
  description: 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.
  measure: 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)
  measure: 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)
  measure: Incidence of maternal admissions
  time frame: Up to 34 weeks from the date of randomization
  measure: Duration of maternal admissions
  time frame: Up to 34 weeks from the date of randomization
  measure: Quality Of Life during pregnancy and during neonatal admission at a neonatal intensive care unit
  time frame: Trough study completion, on avarage 1 year
  description: Using EQ5D questionnaire (5 questions and scale from 1 to 100)
  measure: 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)
  description: Sepsis (early, late and culture negative), number of episodes (min 72 hours) of antibiotic treatment, duration of antibiotic treatment in days
  measure: 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)
  description: Proportion of each category (no, mild, moderate and severe)
  measure: 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)
  description: Incidence
  measure: 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)
  description: Incidence
  measure: 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)
  description: 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
  measure: 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)
  description: Incidence
  measure: 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)
  description: Incidence
  measure: Neonatal outcome: birth weight
  time frame: After the neonate is born
  measure: Effect of antibiotics on the vaginal microbiome
  time frame: During pregnancy until 28 days after PPROM
  description: When the patient is admitted in case the pregnancy was complicated with PPROM
  measure: Effect on the gastrointestinal microbiome of the neonate in case of PPROM
  time frame: Between 13 to 36 weeks from the date of randomization
  description: When the neonate is born after a pregnancy complicated with PPROM
  measure: Placental microbiome in case of preterm birth
  time frame: Between 13 to 36 weeks from the date of randomization
  description: In case the pregnancy was complicated with preterm birth (delivery before 37 weeks of gestation)
  arm group label: Synbiotics
  arm group type: Experimental
  description: Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Matching placebo
  intervention type: Other
  intervention name: Synbiotics
  description: Oral synbiotic (food supplement) containing 8 probiotic Lactobacillus strains, the prebiotics inulin, fructooligosaccharides (FOS) and D-mannose.
  arm group label: Synbiotics
  intervention type: Other
  intervention name: Placebo
  description: Matching placebo
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Caroline Van Holsbeke, PhD
  phone: 003289327521
  email: Caroline.van.holsbeke@zol.be
  last name: Katrien Nulens, MD
  phone: 003289327521
  email: Katrien_Nulens@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Premature Birth
  sharing ipd: Undecided