GBS Rectovaginal ColonizationNCT05156333
Probiotics and GBS Colonization in Pregnancy
A study testing Respecta in people with GBS Rectovaginal Colonization and Neonatal Sepsis, run by University of Modena and Reggio Emilia at 3 sites in Italy.
Trial summary
Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk. 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
- GBS Rectovaginal Colonization, Neonatal Sepsis
- What is being tested?
- Respecta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Oct 2020to 31 Dec 2022
- 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
- low obstetric risk pregnant women by the 33rd week of gestation,
- vaginal delivery expected.
Who cannot join
- positive urine culture for GBS,
- previous newborn suffering from early sepsis,
- use of antibiotics in the month prior to enrollment,
- women unable to understand the study and sign informed consent.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale dei Bambini "Vittore Buzzi"
Milan, MI, 20154
University Hospital of Modena
Modena, 41124
Arcispedale Santa Maria Nuova Reggio Emilia
Reggio Emilia, RE, 42123
About this study
Official title: Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization
Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.
Read the detailed description
Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.
The study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.
Intervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.
- Conditions
- GBS Rectovaginal Colonization, Neonatal Sepsis
- Being tested
- Respecta
- Keywords
- Probiotics, Pregnancy, GBS colonization
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespectaDietary supplement
Also called Probiotic
Respecta® complex (mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171).
Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily oral administration of 1 capusle of placebo, composed of: hydroxypropylmethylcellulose; Anti-caking agent: Magnesium salts of fatty acids, Dioxide of silicon; Dye: E171. Receives: Dietary Supplement: Respecta |
| Probiotic | Active comparator | Daily oral administration of 1 capsule of mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171). Receives: Dietary Supplement: Respecta |
What is being measured
The primary outcome is the main question the study is designed to answer.
GBS Rectovaginal colonization
Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 ^ week).
Measured: at 35-37 weeks
Secondary outcomes (1)
Intrapartum antibiotics profilaxisi
Rata of women requiring antibiotic profilaxis intrapartum
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start15 Oct 2020
- Primary completion30 Sep 2022
- Study completion31 Dec 2022 (estimated)
Why it stopped: Uneffective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBS Rectovaginal ColonizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group study aimed at underestimating the feasibility and effect of the use of probiotic starting from week 30 on vaginal / rectal colonization of GBS in women at low obstetric risk.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Daniela Menichini, Maria Longo
- Responsible party
- Principal investigator, Prof. Fabio Facchinetti, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156333
- Sponsor's protocol ID
- AOU 0025949/19
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Pregnancy and Rectovaginal Group B Streptococcus (GBS) Colonization
- ClinicalTrials.gov ID
- NCT05156333
- Acronym / sponsor ID
- AOU 0025949/19
- Conditions
- GBS Rectovaginal Colonization, Neonatal Sepsis
- Keywords
- Probiotics, Pregnancy, GBS colonization
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Uneffective
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Daniela Menichini, Maria Longo
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Dec 2021 (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.
Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.
Detailed description
Multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women at low obstetric risk.
The study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. It excludes women who during pregnancy had a positive urine culture for GBS, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent.
Intervention Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group study aimed at underestimating the feasibility and effect of the use of probiotic starting from week 30 on vaginal / rectal colonization of GBS in women at low obstetric risk.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: RespectaDaily oral administration of 1 capusle of placebo, composed of: hydroxypropylmethylcellulose; Anti-caking agent: Magnesium salts of fatty acids, Dioxide of silicon; Dye: E171. |
| Probiotic | Active comparator | Dietary Supplement: RespectaDaily oral administration of 1 capsule of mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- low obstetric risk pregnant women by the 33rd week of gestation,
- vaginal delivery expected.
Key exclusion criteria (4 listed)
- positive urine culture for GBS,
- previous newborn suffering from early sepsis,
- use of antibiotics in the month prior to enrollment,
- women unable to understand the study and sign informed consent.
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 |
|---|---|---|
| RespectaAlso: ProbioticRespecta® complex (mixture of probiotics and milk glycoproteins with prebiotic action); Cornstarch; Anti-caking agents: Vegetable magnesium stearate, Silicon dioxide; Capsule orally administered: Hydroxypropylmethylcellulose (coloring: E171). Daily oral administration of two capsules of the Giellepi Spa class IIa medical device "Respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed. | Dietary supplement | Placebo, Probiotic |
Primary outcome
GBS Rectovaginal colonization
Time frame: at 35-37 weeks
Rate of colonized GBS pregnant (carriers) at the time of antepartum screening (35-37 ^ week).
1 secondary outcome
Intrapartum antibiotics profilaxisi
Time frame: during labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respecta in people with GBS Rectovaginal Colonization and Neonatal Sepsis, run by University of Modena and Reggio Emilia at 3 sites 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 4 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: paused, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Results are not available in the source record.
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?
GBS Rectovaginal colonization (time frame: at 35-37 weeks). 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 7 Nov 2022.