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Probiotic

Probiotic dietary supplement for Group B Streptococcal Infection (GRAPE Trial)

Phase 3

Waitlist Available

Led By Katrina Nardini

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Who do not currently ingest an over the counter probiotic supplement (not including yogurt)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (36-37.6 weeks gestational age) and postpartum (day 0-14)

Awards & highlights

GRAPE Trial Summary

This trial is designed to see if taking probiotics while pregnant can reduce the number of women who test positive for Group B Strep at the time of admission to labor and delivery.

Who is the study for?

This trial is for healthy pregnant women aged 18 or older, at 36-37 weeks gestation without obstetric, fetal, or medical complications. They must be GBS positive at 36 weeks, not taking probiotics (except yogurt), attending regular prenatal care before 20 weeks gestation and have no severe allergies to β-lactam antibiotics.Check my eligibility

What is being tested?

The study tests if taking oral probiotics from around week 37 of pregnancy until birth can reduce the number of GBS positive cases upon admission to Labor and Delivery. It's an open-label randomized control trial aiming to set up a larger future study.See study design

What are the potential side effects?

While specific side effects are not listed here, common side effects of probiotics may include digestive discomfort such as gas or bloating. However, these supplements are generally considered safe for most people.

GRAPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not take any probiotic supplements.

GRAPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (36-37.6 weeks gestational age) and postpartum (day 0-14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (36-37.6 weeks gestational age) and postpartum (day 0-14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (36-37.6 weeks gestational age) and postpartum (day 0-14) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GBS culture result (positive versus negative)

Secondary outcome measures

Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) score

Number of participants who report adverse events

Number of participants who report adverse events in their infant

+1 more

GRAPE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Probiotic Dietary SupplementExperimental Treatment1 Intervention

Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.

Group II: Standard of CareActive Control1 Intervention

Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic dietary supplement

2011

N/A

~280

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of New MexicoLead Sponsor

372 Previous Clinical Trials

3,528,721 Total Patients Enrolled

Marquette UniversityOTHER

62 Previous Clinical Trials

200,255 Total Patients Enrolled

Katrina NardiniPrincipal InvestigatorUniversity of New Mexico

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators looking for more participants at this time?

"That is correct. The information available on clinicaltrials.gov suggests that the study is still looking for 75 individuals to take part in the trial at a single location. Originally, the posting went up on December 24th, 2020 but was updated as recently as August 4th, 2022."

Answered by AI

Has the FDA cleared Probiotic for public consumption?

"Probiotic dietary supplements have undergone multiple rounds of testing, with some data supporting efficacy. Therefore, it receives a score of 3 for safety."

Answered by AI

How many people are choosing to participate in this clinical trial?

"That is correct. The clinicaltrial.gov website has the latest information on this trial, which was originally posted on December 24th 2020 and last updated on August 4th 2022. They are currently looking for 75 patients at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Group B Streptococcus Response After Probiotic Exposure

Katrina A. Nardini 2020. "Group B Streptococcus Response After Probiotic Exposure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04721912.

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