- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669094
Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women (PROBIGEST)
Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effectiveness of the Strain Lactobacillus Salivarius V4II-90 in the Reduction of Group B Streptococcus Colonization in Pregnant Women
Study Overview
Status
Intervention / Treatment
Detailed Description
All pregnant women reporting to the clinic in their first trimester of pregnancy (week 11 ± 2 weeks of pregnancy) will be asked to participate in this study. Participation will be voluntary and written informed consent will be obtained from each participant. The study visits will take place in the hospital.
At Visit 1, the inclusion and exclusion criteria will be verified. After signing the informed consent, a physical examination will be performed in addition to a vaginal-rectal smear to detect if they are GBS-positive. Information on the demographic profile and medical history will be collected. The investigator will explain to the participant that she cannot use any probiotic during the course of the study.
At Visit 2, within 21-23 weeks ± 4 days of gestation, the inclusion and exclusion criteria will be reviewed. When a positive result of the microbiological analysis of the vaginal-rectal exudate are obtained, the pregnant GBS+ women will be invited to continue in the study. The randomized participant will intake one capsule of probiotic or placebo every day for the next 12 weeks. The participant will be given a diary and instructions to record the product intake. Adverse events occurring from the time of study inclusion will be recorded. Adverse Events occurring from the time of study inclusion will be recorded.
At the third visit (Visit 3, 35 weeks ± 4 days of gestation), all participants continuing in the study will undergo a general physical examination. A sample of vaginal and rectal exudate will be collected from the participants who end the treatment period. Adverse Events occurring during the period between Visit 2 and Visit 3 will be recorded. The participants must deliver the remaining product and the completed diary.
During Visit 4 (1 month after delivery), all participants will have a general physical examination. Adverse Events occurring since Visit 3 will be recorded. Data will be collected on the delivery and occurrence of early- or late-onset GBS sepsis in the newborn during the first month of life.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy pregnant women, adults (≥ 18 years and under 45 years).
- Before/during week 13 of gestation.
- Signing of informed consent.
Exclusion Criteria:
- Multiple pregnancy.
- Fetal complications.
- History of premature delivery/miscarriage in the second trimester.
- Significant maternal medical complications.
- HIV-positive.
- Women who are immunocompromised (for example, patients with cancer and transplant who are taking certain immunosuppressive drugs, patients with hereditary diseases that affect or could affect the immune system).
- History of significant gastrointestinal disease (e.g., prior gastrointestinal resection, current diarrhea, inflammatory bowel disease).
- Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever or cardiac malformation).
- Use of other probiotics during the current pregnancy.
- Uncertainty of the investigator regarding the willingness or capacity of the participant to comply with the requirements of the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: L. salivarius V4II-90
Lactobacillus salivarius V4II-90; approximately 1*10E9 colony forming unit (CFU) of L. salivarius V4II-90 in 1 oral capsule per day for 12 weeks.
|
7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the Lactobacillus salivarius V4II-90 (1*10E9 CFU) probiotic supplement over a 12 weeks period.
A visit will then be completed one month after delivery.
|
Placebo Comparator: Control group
Placebo supplement in 1 oral capsule per day for 12 weeks.
|
7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the placebo supplement over a 12 weeks period.
A visit will then be completed one month after delivery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants (%) with a vaginal and/or rectal detection of Group B Streptococcus.
Time Frame: 6 months
|
Percentage of participants with a vaginal and/or rectal detection of Group B Streptococcus at the end of the study.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota of vaginal exudates
Time Frame: 6 months
|
Composition of the microbiota of vaginal exudates
|
6 months
|
Microbiota of rectal exudates
Time Frame: 6 months
|
Composition of the microbiota of vaginal exudates
|
6 months
|
Premature membrane rupture
Time Frame: 7 months
|
Percentage of participants with premature rupture of the membranes
|
7 months
|
Premature detachment of the placenta
Time Frame: 7 months
|
Percentage of participants with premature delivery
|
7 months
|
Premature delivery
Time Frame: 7 months
|
Percentage of participants with premature delivery
|
7 months
|
Pregnancy complications
Time Frame: 7 months
|
Percentage of participants with pregnancy complications
|
7 months
|
Newborns with early onset sepsis
Time Frame: 7 months
|
Percentage of newborns with early onset sepsis
|
7 months
|
Newborns with late onset sepsis
Time Frame: 7 months
|
Percentage of newborns with late onset sepsis
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STB/17.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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