Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fecal Microbiota in Preterm Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03975764
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ola Gutzeit MD, Rambam Health Care Campus

Tracking Information
First Submitted Date June 2, 2019
First Posted Date June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date October 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2019)
Unique microbial fingerprint [ Time Frame: 1 year ]
16S rRNA gene sequencing
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fecal Microbiota in Preterm Birth
Official Title Fecal Microbiota in Preterm Birth
Brief Summary We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Fecal semple
Sampling Method Non-Probability Sample
Study Population Woman after vaginal delivery
Condition Gut Microbiome
Intervention Diagnostic Test: Collection of fecal sample
Analysis of fecal microbiome
Study Groups/Cohorts
  • Preterm birth
    Delivery between 24-32 weeks of gestation
    Intervention: Diagnostic Test: Collection of fecal sample
  • Term delivery
    Delivery between 37-41 weeks of gastation
    Intervention: Diagnostic Test: Collection of fecal sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 4, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Woman after vaginal delivery of singleton

Exclusion Criteria:

  • Fetal abnormalities
  • Gestational diabetes
  • Hypertensive disorder
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Ola Gutzeit, MD +972-543088220 stolpnikk@gmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03975764
Other Study ID Numbers 0120-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ola Gutzeit MD, Rambam Health Care Campus
Study Sponsor Rambam Health Care Campus
Collaborators Not Provided
Investigators Not Provided
PRS Account Rambam Health Care Campus
Verification Date June 2019