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

Brief Summary:
We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor

Condition or disease Intervention/treatment
Gut Microbiome Diagnostic Test: Collection of fecal sample

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Fecal Microbiota in Preterm Birth
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
Preterm birth
Delivery between 24-32 weeks of gestation
Diagnostic Test: Collection of fecal sample
Analysis of fecal microbiome

Term delivery
Delivery between 37-41 weeks of gastation
Diagnostic Test: Collection of fecal sample
Analysis of fecal microbiome




Primary Outcome Measures :
  1. Unique microbial fingerprint [ Time Frame: 1 year ]
    16S rRNA gene sequencing


Biospecimen Retention:   Samples Without DNA
Fecal semple


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Woman after vaginal delivery
Criteria

Inclusion Criteria:

  • Woman after vaginal delivery of singleton

Exclusion Criteria:

  • Fetal abnormalities
  • Gestational diabetes
  • Hypertensive disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975764


Contacts
Layout table for location contacts
Contact: Ola Gutzeit, MD +972-543088220 stolpnikk@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus

Layout table for additonal information
Responsible Party: Ola Gutzeit MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03975764     History of Changes
Other Study ID Numbers: 0120-18
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications