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Completed

NCT Number: NCT03611647

Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in Vaginal Microbiome, 16S rRNA

    Time frame: Baseline, and 4-6 weeks after intervention

Secondary outcomes

  1. Change in Rectal Microbiome, 16S rRNA

    Time frame: Baseline, and 4-6 weeks after intervention

  2. Change in Urinary Microbiome, 16S rRNA

    Time frame: Baseline, and 4-6 weeks after intervention

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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