Bacterial VaginosisNCT02744638
Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis
A study testing probiotic yoghurt, chemically acidified milk and Arilin in people with Bacterial Vaginosis, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
Trial summary
The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- probiotic yoghurt, chemically acidified milk and Arilin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be enrolled, the following criteria have to be fulfilled:
- Woman aged ≥ 18 years with stable menstrual cycle or postmenopausal women
- Newly diagnosed bacterial vaginosis based on Amsel criteria
- Complies with a standard oral antibiotic treatment with Metronidazol for 7 days, 2 x 500mg/day)
- Willing to consume for 4 weeks the study product two times daily
- Willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products as well as dietary supplements
- Not in menses at the time of the first examination at the gynaecologist (G1)
- Written informed consent
Who cannot join
- Subjects currently enrolled in another clinical study.
- Subjects having finished another clinical study within the last 4 weeks before inclusion.
- Infection caused by Chlamydia trachomatis
- Infection caused by Neisseria gonorrhoea
- Infection caused by Trichomonas vaginalis
- Infection caused by Candida albicans or other mycosis
Show all 29Show fewer
- Leucocytes present in the vaginal smear
- PAP-testing ≥ 3 (anamnestically)
- Vulvovaginal inflammation as macroscopically identified by the gynaecologist
- Dyspareunia
- Pregnancy and breastfeeding
- Chemically based contraceptives (e.g. suppositories, salves, foam, gel)
- Irregular cycles (e.g. polymenorrhoea, metrorrhagia)
- Dysuria
- Infection of the urinary tract
- Chronic or sporadic abdominal pain with exception of dysmenorrhoea
- Any ano-rectal infection, disease, surgery in the medical history or current
- Anus praeter
- Hypersensitivity, allergy or idiosyncratic reaction to metronidazole or any similar active substances.
- Hypersensitivity, allergy or idiosyncratic reaction to any component of the yoghurt (e.g. lactose intolerance, allergy against milk protein)
- Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria.
- History of hepatitis B and C
- History of HIV infection
- Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
- Major cognitive or psychiatric disorders
- Subjects who are scheduled to undergo hospitalization during the study period
- Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
- Present drug abuse or alcoholism, reformed alcoholic
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, 24118
About this study
Official title: Double-blind, Randomized, Controlled Trial to Evaluate the Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains (L. Crispatus, L. Gasseri, L. Rhamnosus, L. Jensenii) on Bacterial Vaginosis (BV) in Adult Women
The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3 weeks following a standard antibiotic treatment with metronidazole.
Read the detailed description
Female volunteers aged ≥18 years with stable menstrual cycle or postmenopausal women presenting with a newly diagnosed bacterial vaginosis based on Amsel criteria, complying with a standard oral antibiotic treatment (Metronidazol (Arilin®) 7 days 2x500mg), willing to consume for 4 weeks the study product two times daily, complying with the dietary restrictions (s. a.) and complying with the other inclusion and exclusion criteria will be enrolled in the study. After enrollment subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.The study population will be recruited in a screening examination (G1) by gynaecologists from Kiel area. This screening examination (routine examination) by gynaecologist is used to provide the diagnosis BV. After enrolment subjects will be randomly assigned to one of the two test groups verum (n=108) and placebo (n=108).
- Conditions
- Bacterial Vaginosis
- Being tested
- probiotic yoghurt, chemically acidified milk, Arilin
- Keywords
- bacterial vaginosis, probiotics, Amsel Score, Nugent Score
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic yoghurtOther
Also called verum
verum is a liquid probiotic yoghurt containing all four probiotics as described in the arm description. Study participants consume daily two bottles (125g) during an intervention period of four weeks.
chemically acidified milkOther
Also called placebo
Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).
ArilinDrug
Also called Metronidazol
2 tablets Arilin 500mg for 7 days
| Study group | Role | What they receive |
|---|---|---|
| probiotic yoghurt & Arilin | Experimental | probiotic yoghurt, 2 units (125 g), containing living strains of L.crispatus, L.gasseri, L.rhamnosus, L.jensenii, each in a concentration of 1 x 107 CFU/ml product for 4 weeks Two yoghurts are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days Receives: Other: probiotic yoghurt; Drug: Arilin |
| chemically acidified milk & Arilin | Placebo comparator | chemically (H3PO4) acidified milk (125g) without bacterial strains. Two products are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days Receives: Other: chemically acidified milk; Drug: Arilin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of BV-free woman
The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Nugent score
Measured: 4 weeks
Secondary outcomes (2)
Alteration (G2 - G1) of Nugent Score
Measured: 4 weeks
Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center Kiel GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Dairyfem R&D GmbH, University of Natural Resources and Life Sciences
- Responsible party
- Sponsor
- Investigators
- Christiane Laue, Dr. med., Principal investigator, CRC Clinical Research Center Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744638
- Sponsor's protocol ID
- DF-WCT-2014
- Status last verified
- Apr 2016
- First submitted
- 31 Mar 2016
- Last updated
- 17 Nov 2016
- 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 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Controlled Trial to Evaluate the Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains (L. Crispatus, L. Gasseri, L. Rhamnosus, L. Jensenii) on Bacterial Vaginosis (BV) in Adult Women
- ClinicalTrials.gov ID
- NCT02744638
- Acronym / sponsor ID
- DF-WCT-2014
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, probiotics, Amsel Score, Nugent Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Clinical Research Center Kiel GmbHUniversity, hospital or other
- Collaborators
- Dairyfem R&D GmbH, University of Natural Resources and Life Sciences
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Apr 2016 (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, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3 weeks following a standard antibiotic treatment with metronidazole.
Detailed description
Female volunteers aged ≥18 years with stable menstrual cycle or postmenopausal women presenting with a newly diagnosed bacterial vaginosis based on Amsel criteria, complying with a standard oral antibiotic treatment (Metronidazol (Arilin®) 7 days 2x500mg), willing to consume for 4 weeks the study product two times daily, complying with the dietary restrictions (s. a.) and complying with the other inclusion and exclusion criteria will be enrolled in the study. After enrollment subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.The study population will be recruited in a screening examination (G1) by gynaecologists from Kiel area. This screening examination (routine examination) by gynaecologist is used to provide the diagnosis BV. After enrolment subjects will be randomly assigned to one of the two test groups verum (n=108) and placebo (n=108).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic yoghurt & Arilin | Experimental | Other: probiotic yoghurt, Drug: Arilinprobiotic yoghurt, 2 units (125 g), containing living strains of L.crispatus, L.gasseri, L.rhamnosus, L.jensenii, each in a concentration of 1 x 107 CFU/ml product for 4 weeks Two yoghurts are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days |
| chemically acidified milk & Arilin | Placebo comparator | Other: chemically acidified milk, Drug: Arilinchemically (H3PO4) acidified milk (125g) without bacterial strains. Two products are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Woman aged ≥ 18 years with stable menstrual cycle or postmenopausal women
- Newly diagnosed bacterial vaginosis based on Amsel criteria
- Complies with a standard oral antibiotic treatment with Metronidazol for 7 days, 2 x 500mg/day)
- Willing to consume for 4 weeks the study product two times daily
- Willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products as well as dietary supplements
Key exclusion criteria (29 listed)
- Subjects currently enrolled in another clinical study.
- Subjects having finished another clinical study within the last 4 weeks before inclusion.
- Infection caused by Chlamydia trachomatis
- Infection caused by Neisseria gonorrhoea
- Infection caused by Trichomonas vaginalis
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 yoghurtAlso: verumverum is a liquid probiotic yoghurt containing all four probiotics as described in the arm description. Study participants consume daily two bottles (125g) during an intervention period of four weeks. | Other | probiotic yoghurt & Arilin |
| chemically acidified milkAlso: placeboPlacebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned). | Other | chemically acidified milk & Arilin |
| ArilinAlso: Metronidazol2 tablets Arilin 500mg for 7 days | Drug | chemically acidified milk & Arilin, probiotic yoghurt & Arilin |
Primary outcome
Rate of BV-free woman
Time frame: 4 weeks
The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Nugent score
2 secondary outcomes
Alteration (G2 - G1) of Nugent Score
Time frame: 4 weeks
Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2
Time frame: 4 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 17 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
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
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
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Christiane Laue, Dr. med. principal investigator
CRC Clinical Research Center Kiel
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 yoghurt, chemically acidified milk and Arilin in people with Bacterial Vaginosis, run by Clinical Research Center Kiel GmbH at 1 site in Germany.
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 8 inclusion and 29 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 17 Nov 2016. 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 Germany. 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?
Rate of BV-free woman (time frame: 4 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 17 Nov 2016.