Gut MicrobiomeNCT03975764
Fecal Microbiota in Preterm Birth
An observational study of Gut Microbiome, run by Rambam Health Care Campus.
Trial summary
We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gut Microbiome
- What is being tested?
- Collection of fecal sample
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Woman after vaginal delivery
Who may be able to join
- Woman after vaginal delivery of singleton
Who cannot join
- Fetal abnormalities
- Gestational diabetes
- Hypertensive disorder
Trial locations and contacts
No sites are listed yet.
About this study
We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor
- Conditions
- Gut Microbiome
- Being tested
- Collection of fecal sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of fecal sampleDiagnostic test
Analysis of fecal microbiome
| Study group | Role | What they receive |
|---|---|---|
| Preterm birth | Delivery between 24-32 weeks of gestation Receives: Diagnostic Test: Collection of fecal sample | |
| Term delivery | Delivery between 37-41 weeks of gastation Receives: Diagnostic Test: Collection of fecal sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unique microbial fingerprint
16S rRNA gene sequencing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Gutzeit MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975764
- Sponsor's protocol ID
- 0120-18
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota in Preterm Birth
- ClinicalTrials.gov ID
- NCT03975764
- Acronym / sponsor ID
- 0120-18
- Conditions
- Gut Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will compeer fecal microbiome in preterm birth with fecal microbiome of team labor
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm birth | – | Diagnostic Test: Collection of fecal sampleDelivery between 24-32 weeks of gestation |
| Term delivery | – | Diagnostic Test: Collection of fecal sampleDelivery between 37-41 weeks of gastation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Woman after vaginal delivery
Key inclusion criteria (1 listed)
- Woman after vaginal delivery of singleton
Key exclusion criteria (3 listed)
- Fetal abnormalities
- Gestational diabetes
- Hypertensive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of fecal sampleAnalysis of fecal microbiome | Diagnostic test | Preterm birth, Term delivery |
Primary outcome
Unique microbial fingerprint
Time frame: 1 year
16S rRNA gene sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Gut Microbiome
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiome, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola Gutzeit, MD (+972-543088220, stolpnikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unique microbial fingerprint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.