Gestational MotherPROBIGESTNCT03669094
Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women
A study testing Lactobacillus salivarius V4II-90 in people with Gestational Mother and Streptococcus Agalactiae Infection, run by ProbiSearch SL at 1 site in Spain.
Trial summary
An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B Streptococcus (GBS) colonization in pregnant women who are GBS carriers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Mother, Streptococcus Agalactiae Infection
- What is being tested?
- Lactobacillus salivarius V4II-90
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2018to 4 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women, adults (≥ 18 years and under 45 years).
- Before/during week 13 of gestation.
- Signing of informed consent.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B Streptococcus (GBS) colonization in pregnant women who are GBS carriers. Forty GBS-positive participants in their first trimester of pregnancy will be randomly assigned to one of the two study groups: The experimental group with 3 months probiotic consumption; and the control group with 3 months placebo consumption. The efficacy of the probiotic strain to reduce the incidence of Group B Streptococcus will be assessed by the percentage of participants with a vaginal and/or rectal detection of Group B Streptococcus at the end of the study, by bilateral comparison of the treatment group with the control group at the same time period. The estimated duration of the study will be 30 weeks, which includes a 3-month product administration. The intervention will start at week 23 ± 4 days of pregnancy and end at week 35 ± 4 days. Then, a visit will be completed one month after delivery.
Read the 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.
- Being tested
- Lactobacillus salivarius V4II-90, Placebo
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus salivarius V4II-90Dietary supplement
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.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| L. salivarius V4II-90 | Active comparator | 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. Receives: Dietary Supplement: Lactobacillus salivarius V4II-90 |
| Control group | Placebo comparator | Placebo supplement in 1 oral capsule per day for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants (%) with a vaginal and/or rectal detection of Group B Streptococcus.
Percentage of participants with a vaginal and/or rectal detection of Group B Streptococcus at the end of the study.
Measured: 6 months
Secondary outcomes (8)
Microbiota of vaginal exudates
Composition of the microbiota of vaginal exudates
Measured: 6 months
Microbiota of rectal exudates
Composition of the microbiota of vaginal exudates
Measured: 6 months
Premature membrane rupture
Percentage of participants with premature rupture of the membranes
Measured: 7 months
Premature detachment of the placenta
Percentage of participants with premature delivery
Measured: 7 months
Premature delivery
Percentage of participants with premature delivery
Measured: 7 months
Pregnancy complications
Percentage of participants with pregnancy complications
Measured: 7 months
Newborns with early onset sepsis
Percentage of newborns with early onset sepsis
Measured: 7 months
Newborns with late onset sepsis
Percentage of newborns with late onset sepsis
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start5 Dec 2018
- Primary completion2 Aug 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational MotherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional randomized, multicenter, double-blind, placebo-controlled, parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Casen Recordati S.L.
- Responsible party
- Sponsor
- Investigators
- Susana Manzano, PhD, Study chair, ProbiSearch SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669094
- Sponsor's protocol ID
- STB/17.02
- Acronym
- PROBIGEST
- Status last verified
- Mar 2022
- First submitted
- 30 Aug 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Galvez A, Di Az de Teran E, Espinosa JA, Perez-Pedregosa J, Bartha-Rasero JL, Del Valle JG, Cuerva MJ, Jimenez E, Badiola C. Ligilactobacillus salivarius V4II-90 eradicates Group B Streptococcus colonisation during pregnancy: a randomised, double-blind, placebo-controlled trial. Benef Microbes. 2024 Jun 28;15(4):387-396. doi: 10.1163/18762891-bja00021.
PubMed 38955352
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03669094
- Acronym / sponsor ID
- PROBIGEST / STB/17.02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Collaborators
- Casen Recordati S.L.
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B Streptococcus (GBS) colonization in pregnant women who are GBS carriers. Forty GBS-positive participants in their first trimester of pregnancy will be randomly assigned to one of the two study groups: The experimental group with 3 months probiotic consumption; and the control group with 3 months placebo consumption. The efficacy of the probiotic strain to reduce the incidence of Group B Streptococcus will be assessed by the percentage of participants with a vaginal and/or rectal detection of Group B Streptococcus at the end of the study, by bilateral comparison of the treatment group with the control group at the same time period. The estimated duration of the study will be 30 weeks, which includes a 3-month product administration. The intervention will start at week 23 ± 4 days of pregnancy and end at week 35 ± 4 days. Then, a visit will be completed one month after delivery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an interventional randomized, multicenter, double-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| L. salivarius V4II-90 | Active comparator | Dietary Supplement: Lactobacillus salivarius V4II-90Lactobacillus salivarius V4II-90; approximately 1*10E9 colony forming unit (CFU) of L. salivarius V4II-90 in 1 oral capsule per day for 12 weeks. |
| Control group | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplement in 1 oral capsule per day for 12 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pregnant women, adults (≥ 18 years and under 45 years).
- Before/during week 13 of gestation.
- Signing of informed consent.
Key exclusion criteria (10 listed)
- Multiple pregnancy.
- Fetal complications.
- History of premature delivery/miscarriage in the second trimester.
- Significant maternal medical complications.
- HIV-positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus salivarius V4II-907 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. | Dietary supplement | L. salivarius V4II-90 |
| Placebo7 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. | Dietary supplement | Control group |
Primary outcome
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.
8 secondary outcomes
Microbiota of vaginal exudates
Time frame: 6 months
Microbiota of rectal exudates
Time frame: 6 months
Premature membrane rupture
Time frame: 7 months
Premature detachment of the placenta
Time frame: 7 months
Premature delivery
Time frame: 7 months
Pregnancy complications
Time frame: 7 months
Newborns with early onset sepsis
Time frame: 7 months
Newborns with late onset sepsis
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 38955352Galvez A, Di Az de Teran E, Espinosa JA, Perez-Pedregosa J, Bartha-Rasero JL, Del Valle JG, Cuerva MJ, Jimenez E, Badiola C. Ligilactobacillus salivarius V4II-90 eradicates Group B Streptococcus colonisation during pregnancy: a randomised, double-blind, placebo-controlled trial. Benef Microbes. 2024 Jun 28;15(4):387-396. doi: 10.1163/18762891-bja00021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Manzano, PhD study chair
ProbiSearch SL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus salivarius V4II-90 in people with Gestational Mother and Streptococcus Agalactiae Infection, run by ProbiSearch SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants (%) with a vaginal and/or rectal detection of Group B Streptococcus. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.