Genitourinary; Infection, Complicating PregnancyNCT06231056
Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection
A study testing Probiotic iNatal® in people with Genitourinary; Infection, Complicating Pregnancy, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity. 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
- Genitourinary; Infection, Complicating Pregnancy
- What is being tested?
- Probiotic iNatal®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Jun 2023
- 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
- Pregnant women in 24-36 weeks of gestation period
- History of recurrent genitourinary and/or intestinal problems
Who cannot join
- Presence of neurological condition
- History of cardiovascular disease
- History of pulmonary disease
- History of renal disease
- Cancer
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Obstetrics and Gynecology PERUGIA HOSPITAL
Perugia, 06122
About this study
Official title: Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth
Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.
Read the detailed description
There is strong scientific evidence that supports the correlation between bacterial vaginosis (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth. Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and the onset of BV. The latter, however, are not without risks, as they can in turn cause alterations in the vaginal microbiota and is associated with an increased risk of miscarriage.
Recent research have shown that probiotic treatment can help reduc the risk of preterm birth and positivity of Group B β-hemolytic streptococcus (GBS) infection.
The present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as prophylaxis of GBS infections and urine culture positivity.
This was a retrospective, observational, controlled and single centre study.
- Being tested
- Probiotic iNatal®
- Medical subject headings
- Infections, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic iNatal®Dietary supplement
iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplement group | Experimental | Participants in this group received probiotic iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) - dosage 1 sachet per day, during the 24-36 weeks of their gestation period. Receives: Dietary Supplement: Probiotic iNatal® |
| Control group | No intervention | No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological assessment
Control of bacteriuria by urine culture (number of participants)
Measured: 12 weeks
Bacteriological assessment
Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab
Measured: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of Prelabor rupture of membranes (PROM)
Measured: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of Preterm PROM (PPROM)
Measured: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of Preterm birth
Measured: 12 weeks
clinical assessments at the end of pregnancy
Rate of natural or caesarean section mode
Measured: 12 weeks
Clinical assessments at the end of pregnancy
Incidence of induction of child birth
Measured: 12 weeks
Secondary outcomes (1)
Rate of incidence of side effects
Number of participants presenting any side effects
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary; Infection, Complicating PregnancyStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Probiotic supplement group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231056
- Sponsor's protocol ID
- LUMHS/iNatal/20.01.2024
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth
- ClinicalTrials.gov ID
- NCT06231056
- Acronym / sponsor ID
- LUMHS/iNatal/20.01.2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Jan 2024 (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.
Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.
Detailed description
There is strong scientific evidence that supports the correlation between bacterial vaginosis (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth. Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and the onset of BV. The latter, however, are not without risks, as they can in turn cause alterations in the vaginal microbiota and is associated with an increased risk of miscarriage.
Recent research have shown that probiotic treatment can help reduc the risk of preterm birth and positivity of Group B β-hemolytic streptococcus (GBS) infection.
The present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as prophylaxis of GBS infections and urine culture positivity.
This was a retrospective, observational, controlled and single centre study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Probiotic supplement group
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplement group | Experimental | Dietary Supplement: Probiotic iNatal®Participants in this group received probiotic iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) - dosage 1 sachet per day, during the 24-36 weeks of their gestation period. |
| Control group | No intervention | –No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women in 24-36 weeks of gestation period
- History of recurrent genitourinary and/or intestinal problems
Key exclusion criteria (5 listed)
- Presence of neurological condition
- History of cardiovascular disease
- History of pulmonary disease
- History of renal disease
- Cancer
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 |
|---|---|---|
| Probiotic iNatal®iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) | Dietary supplement | Probiotic supplement group |
Primary outcome
Bacteriological assessment
Time frame: 12 weeks
Control of bacteriuria by urine culture (number of participants)
Bacteriological assessment
Time frame: 12 weeks
Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab
Clinical assessments at the end of pregnancy
Time frame: 12 weeks
Incidence of Prelabor rupture of membranes (PROM)
Clinical assessments at the end of pregnancy
Time frame: 12 weeks
Incidence of Preterm PROM (PPROM)
Clinical assessments at the end of pregnancy
Time frame: 12 weeks
Incidence of Preterm birth
clinical assessments at the end of pregnancy
Time frame: 12 weeks
Rate of natural or caesarean section mode
Clinical assessments at the end of pregnancy
Time frame: 12 weeks
Incidence of induction of child birth
1 secondary outcome
Rate of incidence of side effects
Time frame: 12 weeks
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 30 Jan 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic iNatal® in people with Genitourinary; Infection, Complicating Pregnancy, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
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 2 inclusion and 5 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 30 Jan 2024. 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 Italy. 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. 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?
Bacteriological assessment (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.