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Group B Streptococcus Response After Probiotic Exposure (GRAPE)

Primary Purpose

Group B Strep Infection

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Probiotic dietary supplement

About this trial

This is an interventional treatment trial for Group B Strep Infection focused on measuring pregnancy, Group B Strep positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• Healthy adult (≥ 18 years of age) pregnant women who are 36 - 37 6/7 weeks gestation at enrollment [calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)]

Group B Streptococcus Positive at 36 weeks gestation with:

No obstetric complication requiring delivery prior to 39 weeks (hypertensive disorder diagnosed prior to enrollment, gestational diabetes, multiple gestation)
No fetal complication (e.g., birth defect, intrauterine growth restriction)
No medical complication (e.g., chronic hypertension, preexisting diabetes mellitus)
Who do not currently ingest an over the counter probiotic supplement (not including yogurt)
Who can both speak and read English or Spanish
Pregnant women who regularly attend UNM prenatal clinics for their prenatal care ("regularly attend" will be defined as starting prenatal care prior to 20 weeks gestation and missing no more than one prenatal appointment during this pregnancy)
No hypersensitivity reaction to β-lactam antibiotics

Exclusion Criteria:

Those less than 18 years of age
Non-pregnant women
Later in pregnancy than 38 weeks gestation at enrollment [per LNMP and/or US]
Those with an obstetric, fetal or medical complication of pregnancy
Group B Streptococcus negative at 36 weeks gestation. Those ineligible for testing at 36 weeks gestation (history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child.) We will not exclude those with bacteriuria other than GBS, and we will not exclude women who have taken an antibiotic during pregnancy, but we will track this as it is addressed in the Questionnaire for Women.
Women who are currently ingesting an over the counter probiotic supplement (except for yogurt)
Women who do not have electricity in the home.
Women who are planning an elective repeat cesarean birth
Women who do not speak and read English or Spanish
Women with a history of missing one or more scheduled prenatal visit during this pregnancy
Hypersensitivity reaction to β-lactam antibiotics

Sites / Locations

University of New Mexico Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Probiotic Dietary Supplement

Arm Description

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

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.

Outcomes

Primary Outcome Measures

GBS culture result (positive versus negative)

Qualitative GBS colonization (positive versus negative), at the time of admission to Labor and Delivery.

Secondary Outcome Measures

Probiotic pill count to measure intervention adherence

Intervention adherence by pill count for probiotic participants

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

Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)

Number of participants who report adverse events

Maternal adverse events by organ system and severity

Number of participants who report adverse events in their infant

Infant adverse events by organ system and severity

Full Information

NCT ID

NCT04721912

First Posted

December 7, 2020

Last Updated

May 9, 2023

Sponsor

University of New Mexico

Collaborators

Marquette University

1. Study Identification

Unique Protocol Identification Number

NCT04721912

Brief Title

Group B Streptococcus Response After Probiotic Exposure

Acronym

GRAPE

Official Title

Open-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 24, 2020 (Actual)

Primary Completion Date

February 16, 2023 (Actual)

Study Completion Date

February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of New Mexico

Collaborators

Marquette University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. We hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L&D). In this study we aim to determine whether such a study is acceptable in our population, whether any adverse events are identified, and what barriers or confounding variables might exist to probiotic use at term. We will also look at whether probiotic use had any reported effect on maternal gastrointestinal (GI) symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Group B Strep Infection

Keywords

pregnancy, Group B Strep positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Model Description

Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs No Probiotic (standard of care)). The Probiotic group will take one capsule daily and have the same study measures at the same times.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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

Arm Title

Probiotic Dietary Supplement

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Probiotic dietary supplement

Other Intervention Name(s)

Florajen Digestion™

Intervention Description

GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.

Primary Outcome Measure Information:

Title

GBS culture result (positive versus negative)

Description

Qualitative GBS colonization (positive versus negative), at the time of admission to Labor and Delivery.

Time Frame

36 - 42 weeks gestational age (admission to Labor and Delivery)

Secondary Outcome Measure Information:

Title

Probiotic pill count to measure intervention adherence

Description

Intervention adherence by pill count for probiotic participants

Time Frame

Postpartum (day 0-14)

Title

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

Description

Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)

Time Frame

Baseline (36-37.6 weeks gestational age) and postpartum (day 0-14)

Title

Number of participants who report adverse events

Description

Maternal adverse events by organ system and severity

Time Frame

Weekly prenatal visits starting at time of enrollment until time of delivery (37-42 weeks gestational age and 2 weeks and 6 weeks postpartum visits)

Title

Number of participants who report adverse events in their infant

Description

Infant adverse events by organ system and severity

Time Frame

2 weeks and 6 weeks postpartum visits

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Healthy adult (≥ 18 years of age) pregnant women who are 36 - 37 6/7 weeks gestation at enrollment [calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)] Group B Streptococcus Positive at 36 weeks gestation with: No obstetric complication requiring delivery prior to 39 weeks (hypertensive disorder diagnosed prior to enrollment, gestational diabetes, multiple gestation) No fetal complication (e.g., birth defect, intrauterine growth restriction) No medical complication (e.g., chronic hypertension, preexisting diabetes mellitus) Who do not currently ingest an over the counter probiotic supplement (not including yogurt) Who can both speak and read English or Spanish Pregnant women who regularly attend UNM prenatal clinics for their prenatal care ("regularly attend" will be defined as starting prenatal care prior to 20 weeks gestation and missing no more than one prenatal appointment during this pregnancy) No hypersensitivity reaction to β-lactam antibiotics Exclusion Criteria: Those less than 18 years of age Non-pregnant women Later in pregnancy than 38 weeks gestation at enrollment [per LNMP and/or US] Those with an obstetric, fetal or medical complication of pregnancy Group B Streptococcus negative at 36 weeks gestation. Those ineligible for testing at 36 weeks gestation (history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child.) We will not exclude those with bacteriuria other than GBS, and we will not exclude women who have taken an antibiotic during pregnancy, but we will track this as it is addressed in the Questionnaire for Women. Women who are currently ingesting an over the counter probiotic supplement (except for yogurt) Women who do not have electricity in the home. Women who are planning an elective repeat cesarean birth Women who do not speak and read English or Spanish Women with a history of missing one or more scheduled prenatal visit during this pregnancy Hypersensitivity reaction to β-lactam antibiotics

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katrina Nardini

Organizational Affiliation

University of New Mexico

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of New Mexico Hospital

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87112

Country

United States

12. IPD Sharing Statement

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Group B Streptococcus Response After Probiotic Exposure

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