Summary

for females ages 18 years and up (full criteria)
at Sacramento, California
study started
estimated completion
Albert Liu, MD

Description

Summary

The purpose as well as the aim of this project is to understand the effect of probiotics on gastrointestinal (GI) dysfunction such as nausea, vomiting, and constipation that are found during the first and second trimesters of pregnancy. The primary objective of this project is to uncover whether probiotics have an effect on GI functional disorders. The secondary objective is to identify the microbiota associated with probiotic intake. The tested hypothesis is that gut microbiota influences the GI functions and may influence constipation, nausea, and vomiting during pregnancy.

Keywords

Pregnancy Early Nausea Gravidarum Vomiting of Pregnancy Vomiting Probiotic 10 (Nature's Bounty)

Eligibility

You can join if…

Open to females ages 18 years and up

  • First and second trimester healthy or low risk pregnant women who report gastrointestinal disorders such as nausea, vomiting, and constipation

Definition of healthy or low risk pregnant women:

  • Systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg
  • Hemoglobin ≥ 10.0 g/dL
  • Have immunity against rubella (German measles)
  • HIV negative
  • Urine test shows no sign of kidney or urinary tract infection
  • 27 weeks 6 days gestation or less with confirmed fetal heart beat
  • Pregnant women age 18 and older

You CAN'T join if...

  • High risk pregnant women who have existing health conditions such as high blood pressure, Type 1 diabetes, HIV positive, or are infected with Hepatitis B, Syphilis, or other sexually transmitted diseases
  • Pregnant women who have multiple gestations or a history of recurrent miscarriages (more than two consecutive miscarriages)
  • Had prior bariatric surgery
  • Conceived through IVF program
  • Pregnant women who have had severe weight loss (more than 5 pounds) during pregnancy. [Note: Mild weight loss (2-3 pounds) due to nausea, vomiting, or loss of appetite is considered normal.]
  • Medical history of irritable bowel syndrome or other non-pregnancy related GI dysfunction/disorder

Location

  • University of California, Davis accepting new patients
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT03320226
Study Type
Interventional
Last Updated