Back to resultsLacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota
Primary Purpose
Bacterial Vaginosis, Candidosis Vaginal, Urinary Tract Infections
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis
Eligibility Criteria
Inclusion Criteria: Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, subjective vaginal discomfort); Presence of at least 3 Amsel criteria; Nugent score greater than 7; Lactobacillary grade greater than 2 (LBG) (according to Donders classification); Vaginal dysbiosis based on microbial cell count. Exclusion Criteria: Presence of sexually transmitted diseases due to Chlamydia, Neisseria gonorrhoeae or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis; Clinically evident herpes simplex infection; Human papillomavirus or human immunodeficiency virus infections; Use of antibiotics, antifungals, probiotics, or immunosuppressants within the past four weeks; Use of vaginal contraceptives and any other physiological or pathological condition that could potentially interfere with the results of the study (e.g. pregnancy or breastfeeding, chronic diseases, neoplastic diseases, diabetes, genital tract hemorrhages); Enrollment in other programs that involve the administration of products that may affect the composition of the vaginal microbiota.
Sites / Locations
- University of CataniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (15 billion of Colony Forming Units/capsule) for 10 days
1 daily capsule of placebo
Outcomes
Primary Outcome Measures
Microbiota
Change in the composition of the vaginal microbiota (significant reduction of pathogens responsible for vaginal dysbiosis and concomitant increase in lactobacilli)
Symptomatology
Change of signs (leucorrhoea, vulvovaginal erythema/edema) and symptoms (vulvar discomfort, burning, itching) associated to vaginal dysbiosis. Clinical signs and symptoms will be evaluated through a severity score on a scale of 0 (absent or normal) to 3 (severe).
Sign
Absence of inflammation according to Amsel's criteria and Nugent score between 0 and 3
Secondary Outcome Measures
Well-being
Change in the quality of life, based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.
Full Information
NCT ID
NCT05796921
First Posted
March 21, 2023
Last Updated
April 6, 2023
Sponsor
Agnese Maria Chiara Rapisarda
Collaborators
ProBioEtna
1. Study Identification
Unique Protocol Identification Number
NCT05796921
Brief Title
Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota
Official Title
Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Agnese Maria Chiara Rapisarda
Collaborators
ProBioEtna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present randomized double-blind placebo-controlled trial is to evaluate the efficacy of a probiotic formulation, containing the probiotic strain Lacticaseibacillus rhamnosus CA15 (DSM 33960), in the treatment of vaginal dysbiosis in terms of: (i) modulation of the microbiota (increase of lactobacilli and decrease of pathogens), (ii) reduction of clinical signs of inflammation, (iii) improvement of quality of life.
Detailed Description
The aim of the present randomized double-blind placebo-controlled study is to evaluate the ability of the potential probiotic Lacticaseibacillus rhamnosus CA15 (DSM 33960) strain, orally administrated, to balance the vaginal microbiota of women with vaginal dysbiosis. Two hundred women, with signs and symptoms of vaginal dysbiosis, are recruited and randomly allocated to receive oral capsules containing the L. rhamnosus CA15 (DSM 33960) strain or placebo once daily for 10 days. Clinical and microbiological parameters are evaluated in three scheduled appointments: at baseline (T0), 10 days after the start of the treatment (T1), and 30 days after the end of the treatment (T2). In addition, at baseline (T0) and 30 days after the end of the treatment (T2), the quality of life will be evaluated through a quality of life assessment questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis, Candidosis Vaginal, Urinary Tract Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized double-blind placebo-control
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
1 daily capsule of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain (15 billion of Colony Forming Units/capsule) for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 daily capsule of placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain
Other Intervention Name(s)
probiotic CA15
Intervention Description
Patients allocated to the probiotic arm will take the dietary supplement, containing 15 billion of the Lacticaseibacillus rhamnosus CA15 (DSM 33960) probiotic strain, once a day for 10 consecutive days.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Patients allocated to placebo arm will take placebo capsules once a day for 10 consecutive days.
Primary Outcome Measure Information:
Title
Microbiota
Description
Change in the composition of the vaginal microbiota (significant reduction of pathogens responsible for vaginal dysbiosis and concomitant increase in lactobacilli)
Time Frame
Baseline; end of the treatment (10 days); wash-out (3 months)
Title
Symptomatology
Description
Change of signs (leucorrhoea, vulvovaginal erythema/edema) and symptoms (vulvar discomfort, burning, itching) associated to vaginal dysbiosis. Clinical signs and symptoms will be evaluated through a severity score on a scale of 0 (absent or normal) to 3 (severe).
Time Frame
Baseline; end of the treatment (10 days); wash-out (3 months)
Title
Sign
Description
Absence of inflammation according to Amsel's criteria and Nugent score between 0 and 3
Time Frame
Baseline; end of the treatment (10 days); wash-out (3 months)
Secondary Outcome Measure Information:
Title
Well-being
Description
Change in the quality of life, based on the Short Form-36 (SF-36) questionnaire. Values ranging from 0 to 100 indicate worst and better outcomes, respectively.
Time Frame
Baseline; end of the treatment (10 days); wash-out (3 months)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women under reproductive age
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, subjective vaginal discomfort);
Presence of at least 3 Amsel criteria;
Nugent score greater than 7;
Lactobacillary grade greater than 2 (LBG) (according to Donders classification);
Vaginal dysbiosis based on microbial cell count.
Exclusion Criteria:
Presence of sexually transmitted diseases due to Chlamydia, Neisseria gonorrhoeae or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
Clinically evident herpes simplex infection;
Human papillomavirus or human immunodeficiency virus infections;
Use of antibiotics, antifungals, probiotics, or immunosuppressants within the past four weeks;
Use of vaginal contraceptives and any other physiological or pathological condition that could potentially interfere with the results of the study (e.g. pregnancy or breastfeeding, chronic diseases, neoplastic diseases, diabetes, genital tract hemorrhages);
Enrollment in other programs that involve the administration of products that may affect the composition of the vaginal microbiota.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco M Panella, Prof
Phone
+390953781102
Email
mpanella@unict.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco M Panella, Prof
Organizational Affiliation
University of Catania
Official's Role
Study Director
Facility Information:
Facility Name
University of Catania
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco M Panella, Prof
Phone
0953781102
Ext
+39
Email
mpanella@unict.it
12. IPD Sharing Statement
Learn more about this trial
Lacticaseibacillus Rhamnosus CA15 (DSM 33960) Strain as a New Driver in Restoring the Normal Vaginal Microbiota
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