Clinical trial NCT03611647: Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
Official title: Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Microbiome
Probiotic
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Vaginal Microbiome, 16S rRNA
timeFrame: Baseline, and 4-6 weeks after intervention
Secondary outcomes:
measure: Change in Rectal Microbiome, 16S rRNA
timeFrame: Baseline, and 4-6 weeks after intervention
measure: Change in Urinary Microbiome, 16S rRNA
timeFrame: Baseline, and 4-6 weeks after intervention
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive
state: California
city: San Diego
country: United States
facility: UCSD, Hillcrest Clinic, Medical Offices South
state: California
city: San Diego
country: United States
facility: UCSD, Sorrento Valley Clinic, Directors Place
state: California
Study officials:
References: