Pregnancy RelatedNCT03611647
Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
A study testing Probiotic in people with Pregnancy Related, run by University of California, San Diego at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant patients ≥ 18 years of age
- Singleton pregnancy
- Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive
La Jolla, California, 92037
UCSD, Hillcrest Clinic, Medical Offices South
San Diego, California, 92103
UCSD, Sorrento Valley Clinic, Directors Place
San Diego, California, 92121
About this study
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.
- Conditions
- Pregnancy Related
- Being tested
- Probiotic, Placebo
- Keywords
- Microbiome, Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.
PlaceboDietary supplement
Placebo, taken by mouth once daily for 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Microbiome, 16S rRNA
Measured: Baseline, and 4-6 weeks after intervention
Secondary outcomes (2)
Change in Rectal Microbiome, 16S rRNA
Measured: Baseline, and 4-6 weeks after intervention
Change in Urinary Microbiome, 16S rRNA
Measured: Baseline, and 4-6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Laurent, MD/PhD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611647
- Sponsor's protocol ID
- 171759
- Status last verified
- Apr 2019
- First submitted
- 30 Jun 2018
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
- ClinicalTrials.gov ID
- NCT03611647
- Acronym / sponsor ID
- 171759
- Conditions
- Pregnancy Related
- Keywords
- Microbiome, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Aug 2018 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant patients ≥ 18 years of age
- Singleton pregnancy
- Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| ProbioticProbiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks. | Dietary supplement | Probiotic |
| PlaceboPlacebo, taken by mouth once daily for 4-6 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in Vaginal Microbiome, 16S rRNA
Time frame: Baseline, and 4-6 weeks after intervention
2 secondary outcomes
Change in Rectal Microbiome, 16S rRNA
Time frame: Baseline, and 4-6 weeks after intervention
Change in Urinary Microbiome, 16S rRNA
Time frame: Baseline, and 4-6 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Pregnancy Related, run by University of California, San Diego at 3 sites in United States.
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 3 inclusion and 19 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: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vaginal Microbiome, 16S rRNA (time frame: Baseline, and 4-6 weeks after intervention). 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 11 Apr 2019.