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Probiotics for In Utero Drug Exposure (PROBIO Trial)
PROBIO Trial Summary
This trial will test whether probiotics can be transmitted from mother to child in utero. Women who are low risk and pregnant will take either probiotics or a placebo between 34 weeks of pregnancy and 10 days post-partum.
PROBIO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROBIO Trial Design
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- You have taken probiotics or foods with active cultures (like fermented milk, kefir, or kombucha) within the past 2 weeks before the study starts.You have an allergy or intolerance to lactose, soy, or yeast.You are currently experiencing pregnancy complications that could affect the health of you or your baby, such as preterm labor, infections, or bleeding. You are also receiving specific treatments for these complications.You have taken antibiotics within the two weeks before being chosen for the study.You have experienced pregnancy complications like giving birth too early, having high blood pressure during pregnancy (called preeclampsia), or having diabetes during pregnancy that required insulin treatment.
- Group 1: postnatal probiotic
- Group 2: prenatal probiotic
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there a risk in taking probiotic supplements during pregnancy?
"While there is some evidence to support the safety of postnatal probiotic, it does not have a Phase 3 rating because efficacy has not been proven."
Are researchers seeking more participants for this experiment?
"Yes, this trial is presently looking for patients to enroll. The clinical trial was initially posted on 4/27/2022 and was last updated on 5/4/2022 according to the information available on clinicaltrials.gov"
Could I be a test subject for this experiment?
"The aim of this trial is to enroll 52 expectant mothers who have had in utero drug exposure. Additionally, these participants must be between 18-42 years old and meet the following criteria: having a low risk pregnancy, being pregnant with one child, intending to breastfeed postpartum, and being randomized between 32 0/7 - 33 6/7 weeks gestation."
Is the age limit for this trial 75 years or younger?
"The age restriction for this clinical trial are patients that must be over 18 but under 42 years old."
How many research participants are being enrolled in this clinical trial?
"Correct, the clinical trial is currently recruiting patients. According to information on clinicaltrials.gov, the first posting was on 4/27/2022 and there have been edits as recently as 5/4/2022. They are looking for 52 individuals total at 1 location."
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