Probiotic on Prevention of GBS Vaginal Infection During Pregnancy

NCT03688321 | Completed DMC

• 1 other identifier: CMUH107-REC2-104
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether oral taking Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 from 28th week of gestation can reduce the GBS colonization rate of vagina and rectum in 35-37 weeks pregnant women as well as during laboring who present with GBS-positive at 28 weeks pregnancy. Through the results of our study, we try to investigate the role of probiotics in preventing the unnecessary tests, admission and antibiotic treatment in newborn with GBS-positive mother who deliver fewer than 4 hours after laboring and the influence of improving cervical diagnostics quality for postpartum Pap testing. Investigators hope the findings may have some effects on GBS sepsis and protocols as well as cervical diagnosis.

Conditions

Infection, Bacterial

Keywords

Probiotics; Group B Streptococcus; Infection; Prevention

Outcome Measures

Primary Outcomes (1)

• Change of GBS result from positive to negative will be measured through GBS test for both vagina and rectum in 35-37 weeks pregnant women and during laboring.

  100 participants with GBS positive result recruit on 28th week gestation for each group will recheck GBS colonization through GBS culture test of vagina and rectum in 35-37 weeks gestation as well as during laboring. The percentage of GBS positive turned to negative in the two time points will be measured for study group and placebo group.

  18 weeks

Secondary Outcomes (1)

• The number of normal, inflammation and atypical squamous cells(ASC-US) of the Papanicolaou Stain(PAP smear test) results for study group and placebo group will be measured through cervical PAP Smear Test on the 6th week after laboring.

  18 weeks

Study Arms (2)

Probiotic capsule GR-1 and RC-14

ACTIVE COMPARATOR

The intervention for study group is taking 2 capsules containing probiotic strains GR-1 and RC-14 before sleep for 18 weeks after being confirmed as GBS positive on 28th week gestation

Dietary Supplement: Probiotic capsule GR-1 and RC-14

Placebo capsule

PLACEBO COMPARATOR

The intervention for placebo group is taking 2 capsules not containing probiotic strains GR-1 and RC-14 before sleep for 18 weeks after being confirmed as GBS positive on 28th week gestation

Dietary Supplement: Placebo capsule

Interventions

Probiotic capsule GR-1 and RC-14 DIETARY_SUPPLEMENT

Study Group will take 2 probiotics capsules containing 1 billion colony forming unit(CFU) of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each before sleep for 18 weeks starting at 28th week gestation

Also known as: U-relax

Probiotic capsule GR-1 and RC-14

Placebo capsule DIETARY_SUPPLEMENT

Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation

Placebo capsule

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old pregnant women
• Singleton pregnancy
• GBS positive confirmed on 28th week gestation with informed consent form
• Agreed to abstain from the use of any systemic or intra-vaginal antibiotic, antifungal agents, or any other intravaginal product(e.g., contraceptive creams, lubricants, and douches) throughout the trial period.

You may not qualify if:

• Multiple gestations
• Impaired immunity, diabetes, or any other kind of significant disease or acute illness that could complicate the evaluation of the results
• Received vaginal or systemic antibiotics and antifungal therapy within 2 weeks of the screening visit
• Allergy or GI dysfunction history after taking probiotics or yogurt
• Constipation

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical Univrsity Hoospital

Taichung, 40447, Taiwan

Location

Related Publications (1)

• Ho M, Chang YY, Chang WC, Lin HC, Wang MH, Lin WC, Chiu TH. Oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 to reduce Group B Streptococcus colonization in pregnant women: A randomized controlled trial. Taiwan J Obstet Gynecol. 2016 Aug;55(4):515-8. doi: 10.1016/j.tjog.2016.06.003.

  PMID: 27590374 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ming Ho, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Labels with CMUH REC No. plus serial numbers on each bottle been completed by manufacturer and deliver to participants followed by random grouping order.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Group: take 2 probiotics capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation Placebo Group: take 2 placebo capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 28, 2018
• Study Start: October 24, 2018
• Primary Completion: August 30, 2020
• Study Completion: June 30, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

TW (1)