A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy

University of California (UC) Davis

Status: Completed

Conditions: Nausea Gravidarum; Pregnancy Early; Vomiting of Pregnancy

Treatments: Dietary Supplement: Probiotic 10 (Nature's Bounty)

Study type: Interventional

Funder types: Other

Identifiers

NCT03320226

1028059

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Probiotic 10 (Nature's Bounty)

Other group

Description:

The suggested dose will be two (2) pills of Probiotic 10 (Nature's Bounty) after dinner daily. Subjects will be asked to take probiotics for six (6) days after providing baseline fecal specimen. Subjects will self-report their daily GI function including the frequency of nausea, vomiting, and bowel movement(s). Then, the subjects will stop taking probiotics for two (2) days and resume taking probiotics for another six (6) days. This six (6)-day on and two (2)- day off cycle is repeated two (2) times.

Treatment:

Dietary Supplement: Probiotic 10 (Nature's Bounty)