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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Early Nausea Gravidarum Vomiting of Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Probiotic 10 (Nature's Bounty)

Dietary Supplement

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.

Primary outcomes

Number of vomiting and nausea per day

Time frame: 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 outcomes

The relative quantity of gut bacteria at phylum, family, and species level when patients take or do not take Probiotic-10.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Oct 25, 2017
Registry last updated: Aug 9, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.

Completed