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Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)

Sponsor
Fertypharm (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05176535
Collaborator
(none)
55
Enrollment
1
Location
1
Arm
17
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: FertyBiotic Balance
 N/A

Detailed Description

After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)
Actual Study Start Date :
Oct 11, 2021
Anticipated Primary Completion Date :
Oct 11, 2022
Anticipated Study Completion Date :
Mar 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: FertyBiotic Balance

Participants received FertyBiotic Balance one capsule a day

Dietary Supplement: FertyBiotic Balance
Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209

Outcome Measures

Primary Outcome Measures

  1. Rectal and vaginal colonization [10 weeks]

    Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen

Secondary Outcome Measures

  1. Autoinmune capacity [10 weeks]

    Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10

  2. Antioxidant effect [10 weeks]

    Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 43 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Aged: 35-43 years old

  • Vaginal pH > 4,5 and low Lactobacillus count or Nugent score of 4-6

  • With interest in getting pregnant and ideally in IVF waiting list

  • History of recurrent genitourinary infections

Exclusion Criteria:

  • Any pathology that interferes with the study

  • Current intake of food supplements or probiotics

  • Current intake of contraceptives

  • Use of oral or vaginal probiotics in the last 6 months

  • Hypersensitivity to any of the components of the studied product

  • Current vaginal infection

  • Pregnant women

  • Breastfeeding

  • Use of intrauterine device

  • Use of spermicide

  • Use of cervical caps as hormonal therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 HM Fertility Centter Vallés Alcalá De Henares Madrid Spain 28801

Sponsors and Collaborators

  • Fertypharm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fertypharm
ClinicalTrials.gov Identifier:
NCT05176535
Other Study ID Numbers:
  • 2021-FBB-07
First Posted:
Jan 4, 2022
Last Update Posted:
Jan 4, 2022
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Communicable Diseases
Infections
Infertility
Dysbiosis

Study Results

No Results Posted as of Jan 4, 2022