Breast CancerNCT01723592
Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.
A study testing Probiotics in people with Breast Cancer, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2012to Oct 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with Nugent scores between 4 and 6
Who cannot join
- Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna - Department of Obstetrics and Gynecology
Vienna, 1090
About this study
Official title: The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics.
Read the detailed description
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale. Improvement of Nugent scores should be considered the primary end point of the study. The outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.
- Conditions
- Breast Cancer
- Being tested
- Probiotics, Oral lactose placebo
- Keywords
- chemotherapy, vaginal flora
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called L.rhamnosus/ LbV96 (DSM 22560), L.jensenii /LbV 116 (DSM 22567), L.crispatus/ Lbv88 (DSM 22566), L.gasseri /LbV 150N (DSM 22583)
Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583)
Oral lactose placeboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 30 participants in this group receive a oral lactose placebo Receives: Dietary Supplement: Oral lactose placebo |
| Probiotics | Active comparator | 30 participants in this group receiving oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains belonging to the species:
L.rhamnosus/ LbV96 (DSM 22560)
L.jensenii /LbV 116 (DSM 22567)
L.crispatus/ Lbv88 (DSM 22566)
L.gasseri /LbV 150N (DSM 22583) Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Nugent score between baseline and end of treatment (improvement or no improvement)
Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent)
Measured: day 0, 7 and day 14 of oral probiotic application
Secondary outcomes (1)
Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic
From each participant, a vaginal swab for microbiologic cultures will be taken on the first day and that following the last administration for Isolation of oral applied probiotic strains as well as non-lactobacilli-flora.
Measured: day 0, 7 and day 14 after oral probiotic application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Natural Resources and Life Sciences, Vienna, Austria
- Responsible party
- Principal investigator, Associate Prof. Ljubomir Petricevic MD, Medical University of Vienna
- Investigators
- Herbert Kiss, MD, Study director, Medical University of Vienna, Dept. of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723592
- Sponsor's protocol ID
- MUW EK 1417/2012
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2012
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT01723592
- Acronym / sponsor ID
- MUW EK 1417/2012
- Conditions
- Breast Cancer
- Keywords
- chemotherapy, vaginal flora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- University of Natural Resources and Life Sciences, Vienna, Austria
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 8 Nov 2012 (estimated)
- 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.
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics.
Detailed description
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale. Improvement of Nugent scores should be considered the primary end point of the study. The outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Oral lactose placebo30 participants in this group receive a oral lactose placebo |
| Probiotics | Active comparator | Dietary Supplement: Probiotics30 participants in this group receiving oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains belonging to the species: L.rhamnosus/ LbV96 (DSM 22560) L.jensenii /LbV 116 (DSM 22567) L.crispatus/ Lbv88 (DSM 22566) L.gasseri /LbV 150N (DSM 22583) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with Nugent scores between 4 and 6
Key exclusion criteria (1 listed)
- Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.
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 |
|---|---|---|
| ProbioticsAlso: L.rhamnosus/ LbV96 (DSM 22560), L.jensenii /LbV 116 (DSM 22567), L.crispatus/ Lbv88 (DSM 22566), L.gasseri /LbV 150N (DSM 22583)Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583) | Dietary supplement | Probiotics |
| Oral lactose placeboPlacebo | Dietary supplement | Placebo |
Primary outcome
change in Nugent score between baseline and end of treatment (improvement or no improvement)
Time frame: day 0, 7 and day 14 of oral probiotic application
Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent)
1 secondary outcome
Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic
Time frame: day 0, 7 and day 14 after oral probiotic application
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 6 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Herbert Kiss, MD study director
Medical University of Vienna, Dept. of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Breast Cancer, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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 6 Jun 2017. 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 Austria. 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?
change in Nugent score between baseline and end of treatment (improvement or no improvement) (time frame: day 0, 7 and day 14 of oral probiotic application). 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 6 Jun 2017.