Status:
COMPLETED
A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
Lead Sponsor:
University of California, Davis
Conditions:
Pregnancy Early
Nausea Gravidarum
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03320226
Start Date
January 9 2018
End Date
April 2 2021
Last Update
August 9 2023
Active Locations (1)
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1
University of California, Davis
Sacramento, California, United States, 95817