Vaginal InfectionNCT04461782
Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota
A study testing Lactobacillus plantarum in people with Vaginal Infection, run by AB Biotics, SA at 1 site in Spain.
Trial summary
Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis. Probiotics are living organisms that provide the host certain benefits. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection
- What is being tested?
- Lactobacillus plantarum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2019to 15 Feb 2020
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade) I, IIa or IIb.
- Using the same contraceptive within 4 weeks prior to study start.
Who cannot join
- Current vaginal infection.
- Vaginal infection 1 month prior to study start.
- Cervico-vaginal pathology.
- Papilloma human virus.
- Pregnant or breastfeeding mothers.
- Using IUD.
Show all 21Show fewer
- Immunomodulators or systemic corticoids intake.
- Vaginal or systemic antibiotics intake 1 month prior to study start.
- Vaginal probiotic intake 1 month prior to study start.
- Less than three months after giving birth or abortion.
- Undergone vaginal or intestinal surgery three months prior to study start.
- Severe stress or depression.
- Systemic acute or severe disease.
- History of alcohol or drug abuse.
- Chronic intestinal pathology.
- Not understanding protocol procedures.
- Use of lubricant 24 hours or spermicide 7 days prior to study start.
- Swallowing difficulties.
- Impossibility to understand study procedures.
- Enrolled in another clinical study.
- Atrophic vaginitis not under treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota
Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis.
Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.
Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.
- Conditions
- Vaginal Infection
- Being tested
- Lactobacillus plantarum
- Keywords
- vaginal probiotic
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarumDietary supplement
Oral food supplement
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum | Experimental | Oral intake 1 cap daily
1E+09 cfu/cap of Lactobacillus plantarum Receives: Dietary Supplement: Lactobacillus plantarum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
Measured: change day 14-23 from baseline
Colonization
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
Measured: change day 42 from baseline
Secondary outcomes (8)
Lactobacillary grade (LBG) score
obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3.
Measured: change day 42 from baseline
Other bacteria in vagina
Detection of other bacteria by metagenomic analysis
Measured: change day 14-23 from baseline
Other bacteria in vagina
Detection of other bacteria by metagenomic analysis
Measured: change day 42 from baseline
Vaginal pH
Measured through urine test strip
Measured: Change day 14-23 from baseline
Vaginal pH
Measured through urine test strip
Measured: Change day 42 from baseline
Product satisfaction
Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied
Measured: day 14-23
Safety and tolerability
Analyzed by the number of adverse events registered during the study
Measured: through study completion, an average of 42 days
Gastrointestinal symptoms
Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc)
Measured: Change day 14-23 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start15 Apr 2019
- Primary completion15 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vaginal InfectionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461782
- Sponsor's protocol ID
- AB-INTIMUS-Colonization
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. doi: 10.1136/pmj.79.934.428.
PubMed 12954951Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.
PubMed 9553803Palacios S, Espadaler J, Fernandez-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9.
PubMed 27393491
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota
- ClinicalTrials.gov ID
- NCT04461782
- Acronym / sponsor ID
- AB-INTIMUS-Colonization
- Conditions
- Vaginal Infection
- Keywords
- vaginal probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 8 Jul 2020 (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.
Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis.
Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.
Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum | Experimental | Dietary Supplement: Lactobacillus plantarumOral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade) I, IIa or IIb.
- Using the same contraceptive within 4 weeks prior to study start.
Key exclusion criteria (21 listed)
- Current vaginal infection.
- Vaginal infection 1 month prior to study start.
- Cervico-vaginal pathology.
- Papilloma human virus.
- Pregnant or breastfeeding mothers.
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 plantarumOral food supplement | Dietary supplement | Lactobacillus plantarum |
Primary outcome
Colonization
Time frame: change day 14-23 from baseline
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
Colonization
Time frame: change day 42 from baseline
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
8 secondary outcomes
Lactobacillary grade (LBG) score
Time frame: change day 42 from baseline
Other bacteria in vagina
Time frame: change day 14-23 from baseline
Other bacteria in vagina
Time frame: change day 42 from baseline
Vaginal pH
Time frame: Change day 14-23 from baseline
Vaginal pH
Time frame: Change day 42 from baseline
Product satisfaction
Time frame: day 14-23
Safety and tolerability
Time frame: through study completion, an average of 42 days
Gastrointestinal symptoms
Time frame: Change day 14-23 from baseline
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 8 Jul 2020.
- Background: PubMed 12954951Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. doi: 10.1136/pmj.79.934.428.
- Background: PubMed 9553803Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.
- Background: PubMed 27393491Palacios S, Espadaler J, Fernandez-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9.
Related trials for Vaginal Infection
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
Safety Study of MucoCept-CVN
HIV -1 Infection
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
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 Lactobacillus plantarum in people with Vaginal Infection, run by AB Biotics, SA 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 2 inclusion and 21 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 8 Jul 2020. 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. 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?
Colonization (time frame: change day 14-23 from baseline). The study lists 2 primary outcomes in all. 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 NCT04461782, which also lists 3 linked publications.
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 8 Jul 2020.