Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

NCT03611647 | Completed

• 1 other identifier: 171759
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Pregnancy Related

Keywords

Microbiome; Probiotic

Outcome Measures

Primary Outcomes (1)

• Change in Vaginal Microbiome, 16S rRNA

  Baseline, and 4-6 weeks after intervention

Secondary Outcomes (2)

• 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

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo, taken by mouth once daily for 4-6 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant patients ≥ 18 years of age
• Singleton pregnancy
• Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (3)

UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive

La Jolla, California, 92037, United States

Location

UCSD, Hillcrest Clinic, Medical Offices South

San Diego, California, 92103, United States

Location

UCSD, Sorrento Valley Clinic, Directors Place

San Diego, California, 92121, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Perinatal Research; Department of Obstetrics, Gynecology, and Reproductive Sciences; Division of Maternal-Fetal Medicine

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: August 2, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)