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

Pregnancy Early Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320226
• Other study ID #: 1028059
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: April 2, 2021

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2, 2021
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea Gravidarum
• Pregnancy Early
• Vomiting
• Vomiting of Pregnancy

Intervention

Dietary Supplement:
• Probiotic 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.

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of vomiting and nausea per day	Using scale of 1-5, quantify the seriousness of sick to the stomach, dry heaves, fatigue, lack of energy, and feeling blue.	16 days following baseline fecal sample collection
Secondary	The relative quantity of gut bacteria at phylum, family, and species level when patients take or do not take Probiotic-10.	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.	16 days following baseline fecal sample collection