Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT03611647
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-06-30
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Vaginal Microbiome, 16S rRNA	Baseline, and 4-6 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
Change in Rectal Microbiome, 16S rRNA	Baseline, and 4-6 weeks after intervention
Change in Urinary Microbiome, 16S rRNA	Baseline, and 4-6 weeks after intervention

Trial Locations

Locations (3)

UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive; 🇺🇸 La Jolla, California, United States

UCSD, Hillcrest Clinic, Medical Offices South; 🇺🇸 San Diego, California, United States

UCSD, Sorrento Valley Clinic, Directors Place; 🇺🇸 San Diego, California, United States