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

Sponsor
University of California, Davis (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03320226
Collaborator
(none)
39
Enrollment
1
Location
1
Arm
50.7
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic 10 (Nature's Bounty)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
Actual Study Start Date :
Jan 9, 2018
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Probiotic 10 (Nature's Bounty)

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Davis Sacramento California United States 95817

Sponsors and Collaborators

  • University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03320226
Other Study ID Numbers:
  • 1028059
First Posted:
Oct 25, 2017
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vomiting

Study Results

No Results Posted as of Nov 22, 2021