Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy

NCT01479478 | Completed Results

• 1 other identifier: 18840
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal antibiotic administration at time of labor. The importance of this study is that it may offer a safer alternative to antibiotic treatment of group B Streptococcus (GBS) colonized pregnant women.

Conditions

Infection; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age

  Gestational age is given in a format of full weeks.

  35 to 37 weeks gestational age

Secondary Outcomes (17)

• Count of Participants With Urinary Tract Infection

  From enrollment up to delivery hospitalization (up to 42 weeks gestation)

• Count of Participants With Intrapartum Chorioamnionitis

  From time of labor onset until delivery (up to 42 weeks of gestation)

• Count of Participants With Endometritis

  From time of delivery up to 6 weeks postpartum

• Count of Participants With Cellulitis

  From time of delivery up to 6 weeks postpartum

• Count of Participants With Bacteremia

  From time of labor onset up to 6 weeks postpartum

Study Arms (2)

Probiotic dietary supplement

ACTIVE COMPARATOR

Probiotic dietary supplement one capsule once per day until delivery.

Dietary Supplement: Probiotic dietary supplement

Placebo

PLACEBO COMPARATOR

Placebo capsule, one daily until delivery.

Drug: Placebo

Interventions

Placebo DRUG

One placebo capsule daily.

Also known as: Sugar pill

Placebo

Probiotic dietary supplement DIETARY_SUPPLEMENT

Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14

Also known as: Other Names:, Jarrow's fem-dophilus

Probiotic dietary supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 20-28 weeks gestation.
• years of age or older.
• Singleton gestation.

You may not qualify if:

• Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ transplant; chronic steroid therapy; autoimmune disease requiring treatment during pregnancy, and other immunocompromised states); Type 1 diabetes and type 2 diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic prophylaxis during procedure/labor; pulmonary disease (except mild asthma); renal disease; chronic hepatic disease (Hepatitis B, C); inflammatory bowel disease (Crohn's disease or ulcerative colitis); stomach or duodenal ulcer; bowel resection, gastric bypass, and chronic indwelling venous, bladder, or gastric catheter.
• Multi-fetal gestation.
• Use of probiotics preparations in the 3 months prior to beginning of the study treatment or use of any additional probiotics preparations (other than study treatment) at any time during the study period (including over the counter food supplements such as Activia, BioK, other oral or vaginal probiotics products (BUT not including other common forms of yogurt).
• Chronic (daily) use of broad spectrum antibiotics.
• History of infant with GBS sepsis.
• Intrauterine Growth Restriction (IUGR), Fetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
• Anticipated delivery \<35 wks for maternal/fetal indication
• Placenta previa or accreta (with anticipated delivery prior to 35 weeks)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (3)

Aptos Women's Health Center

Aptos, California, 95003, United States

Location

Dominican Hospital

Santa Cruz, California, 95065, United States

Location

Stanford University School of Medicine/Lucile Packard Children's Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Natali Aziz, MD
• Organization: Stanford University

mfmresearch@stanford.edu

650-725-5720

Study Officials

• Natali Aziz, MD

  Stanford University School of Medicine/Lucile Packard Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: November 1, 2011
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)