Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora
NCT ID: NCT03923985
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-03-21
2019-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Active Arm
1 tablet / day of probiotic containing 10 Mld L. crispatus during two months
Probiotic containing Lactobacillus Crispatus
1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.
Control Arm
No treatment
No interventions assigned to this group
Interventions
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Probiotic containing Lactobacillus Crispatus
1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.
Eligibility Criteria
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Inclusion Criteria
* Women without current symptoms of vaginal infection
* Negative bacteriological and clinical examination
Exclusion Criteria
* Women with undiagnosed vaginal bleeding
* Patients with endometrial hyperplasia
* Suspicion of neoplasia or active neoplasia
* Women with intolerance, allergy or hypersensitivity to the components of the probiotic
* Women with immunosuppressive disorders or with HIV
* Women who are currently using probiotics by any route of administration
* Women who are using some treatment for vaginal sepsis
* Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
* Pregnant women or those with precocious menopause
18 Years
45 Years
FEMALE
Yes
Sponsors
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Instituto Palacios
OTHER
Responsible Party
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Principal Investigators
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Santiago Palacios, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Palacios
Locations
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Instituto Palacios
Madrid, , Spain
Countries
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Other Identifiers
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SEID-Probiot
Identifier Type: -
Identifier Source: org_study_id
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