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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora

Clinicaltrials.gov identifier NCT03923985

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted April 23, 2019

Study Description

Brief summary:

Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora

  • Condition or Disease:Vaginal Flora
  • Intervention/Treatment: Dietary Supplement: Probiotic containing Lactobacillus Crispatus
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: October 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Active Arm
1 tablet / day of probiotic containing 10 Mld L. crispatus during two months
Dietary Supplement: 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.
Outcome Measures
  • Primary Outcome Measures: 1. Changes in the number of Lactobacillus Crispatus on the vaginal flora [ Time Frame: Screening, month 2 ]
    Analysis of vaginal lactobacilli.
  • Secondary Outcome Measures: 1. Changes in vaginal PH [ Time Frame: Screening, month 2 ]
    PH measurement
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Healthy women between 18 and 45 years old

- Women without current symptoms of vaginal infection

- Negative bacteriological and clinical examination

Exclusion Criteria:

- Women with vaginal infection

- 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

Contacts and Locations
Contacts

Contact: Santiago Palacios, PhD +34 91 578 05 17 ipalacios@institutopalacios.com

Contact: Eva M Soler, SC +34 91 578 05 17 eva.maria.soler@institutopalacios.com

Locations

Spain
Instituto Palacios
Madrid

Sponsors and Collaborators

Instituto Palacios

Investigators

Principal Investigator: Santiago Palacios, PhD Instituto Palacios

More Information
  • Responsible Party: Instituto Palacios
  • ClinicalTrials.gov Identifier: NCT03923985 History of Changes
  • Other Study ID Numbers: SEID-Probiot
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Instituto Palacios: Vaginal Flora Oral Probiotics