Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

Pregnancy Related Clinical Trial

Official title:

Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611647
• Other study ID #: 171759
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vaginal Microbiome, 16S rRNA		Baseline, and 4-6 weeks after intervention
Secondary	Change in Rectal Microbiome, 16S rRNA		Baseline, and 4-6 weeks after intervention
Secondary	Change in Urinary Microbiome, 16S rRNA		Baseline, and 4-6 weeks after intervention