A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy (NCT03320226) | Clinical Trial Compass
CompletedNot Applicable
A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
United States39 participantsStarted 2018-01-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of vomiting and nausea per day
Timeframe: 16 days following baseline fecal sample collection