- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611647
Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
April 9, 2019 updated by: Louise Laurent, MD/PhD, University of California, San Diego
The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet.
Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy.
For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention.
These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing.
The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine.
Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive
-
San Diego, California, United States, 92103
- UCSD, Hillcrest Clinic, Medical Offices South
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San Diego, California, United States, 92121
- UCSD, Sorrento Valley Clinic, Directors Place
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant patients ≥ 18 years of age
- Singleton pregnancy
- Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days
Exclusion Criteria:
- Pregnant patients <18 years of age
- Multiple gestations
- Gestational age less than or equal to 5 weeks and 6 days
- Gestational age greater than or equal to 14 weeks and 0 days
- Institutionalization for psychiatric disorder, mental retardation, or criminal activity
- Inability to provide informed consent
- Major medical complication of pregnancy, including but not limited to: Diabetes, Chronic hypertension, Severe obesity with body mass index greater than or equal to 40 kg/m2
- Major surgical complications of pregnancy, including but not limited to: History of Bariatric surgery
- Major obstetrical complication of pregnancy, including but not limited to: History of spontaneous preterm birth
- Known maternal or fetal chromosomal abnormality
- Major fetal anomaly
- Intrauterine fetal demise
- Human immunodeficiency virus (HIV) or Hepatitis
- Chronic immunosuppressive medications or steroids
- Current use of probiotic supplementation
- Active urinary or vaginal infection
- Current use of antibiotics
- Current use of vaginal medication (e.g. vaginal progesterone)
- Cerclage in place
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
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo, taken by mouth once daily for 4-6 weeks.
|
ACTIVE_COMPARATOR: Probiotic
|
Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Vaginal Microbiome, 16S rRNA
Time Frame: Baseline, and 4-6 weeks after intervention
|
Baseline, and 4-6 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Rectal Microbiome, 16S rRNA
Time Frame: Baseline, and 4-6 weeks after intervention
|
Baseline, and 4-6 weeks after intervention
|
Change in Urinary Microbiome, 16S rRNA
Time Frame: Baseline, and 4-6 weeks after intervention
|
Baseline, and 4-6 weeks after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (ACTUAL)
April 1, 2018
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
December 31, 2018
Study Registration Dates
First Submitted
June 30, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (ACTUAL)
August 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 9, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 171759
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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