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

Not Applicable

Completed

• Conditions: Vomiting of Pregnancy; Pregnancy Early; Nausea Gravidarum
• Interventions: Dietary Supplement: Probiotic 10 (Nature's Bounty)

• Registration Number: NCT03320226
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Study Start: 2018-01-09
• Primary Completion: 2020-03-10
• Study Completion: 2021-04-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic 10 (Nature's Bounty)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States