Fecal Microbiota in Preterm Birth

June 4, 2019 updated by: Ola Gutzeit MD, Rambam Health Care Campus
We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Woman after vaginal delivery

Description

Inclusion Criteria:

  • Woman after vaginal delivery of singleton

Exclusion Criteria:

  • Fetal abnormalities
  • Gestational diabetes
  • Hypertensive disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unique microbial fingerprint
Time Frame: 1 year
16S rRNA gene sequencing
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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