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

Microbial Colonization Clinical Trial

— PROSALVAG  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176535
• Other study ID #: 2021-FBB-07
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: March 11, 2023

Study information

• Verified date: November 2021
• Source: Fertypharm
• Contact: Eva González
• Phone: +34 932 301 260
• Email: egonzález[@]fertypharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: March 11, 2023
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Dysbiosis
• Fertility Issues
• Infections
• Infertility
• Microbial Colonization

Intervention

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

Locations

Country	Name	City	State
Spain	HM Fertility Centter Vallés	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fertypharm

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rectal and vaginal colonization	Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen	10 weeks
Secondary	Autoinmune capacity	Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10	10 weeks
Secondary	Antioxidant effect	Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde	10 weeks