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

Primary Purpose

Pregnancy Early, Nausea Gravidarum, Vomiting of Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probiotic 10 (Nature's Bounty)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pregnancy Early

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Probiotic 10 (Nature's Bounty)

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 11, 2017
Last Updated
August 7, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03320226
Brief Title
A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
Official Title
A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
April 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Early, Nausea Gravidarum, Vomiting of Pregnancy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic 10 (Nature's Bounty)
Arm Type
Other
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic 10 (Nature's Bounty)
Intervention Description
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 Outcome Measure Information:
Title
Number of vomiting and nausea per day
Description
Using scale of 1-5, quantify the seriousness of sick to the stomach, dry heaves, fatigue, lack of energy, and feeling blue.
Time Frame
16 days following baseline fecal sample collection
Secondary Outcome Measure Information:
Title
The relative quantity of gut bacteria at phylum, family, and species level when patients take or do not take Probiotic-10.
Description
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.
Time Frame
16 days following baseline fecal sample collection

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
First and second trimester healthy or low risk pregnant women who report gastrointestinal disorders such as nausea, vomiting, and constipation.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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