Nausea Gravidarum, Pregnancy Early, Vomiting of Pregnancy
Conditions
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 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.
Interventions
DIETARY_SUPPLEMENTProbiotic 10 (Nature's Bounty)
The Probiotic 10 (Nature's Bounty) that contains 20 billion live cultures of Lactobacillus plantarum 299v (Lp299v®), Lactobacillus bulgaricus Lb-87, Lactobacillus paracasei DSM 13434, Lactobacillus plantarum DSM 15312, Lactobacillus salivarius Ls-33, Lactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, Bifidobacterium lactis Bl-04, Lactobacillus paracasei Lpc-37, Lactobacillus casei Lc-11, which are under Lactobacillus and Bifidobacterium.
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of vomiting and nausea per day | 16 days following baseline fecal sample collection | Using scale of 1-5, quantify the seriousness of sick to the stomach, dry heaves, fatigue, lack of energy, and feeling blue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The relative quantity of gut bacteria at phylum, family, and species level when patients take or do not take Probiotic-10. | 16 days following baseline fecal sample collection | To receive at least six (6) analyzable fecal specimens including one prior to taking probiotics from 33 subjects to identify the microbiota associated with probiotic intake. |
Countries
United States
Outcome results
None listed