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

Fertypharm

Status: Completed

Conditions: Dysbiosis; Microbial Colonization; Fertility Issues

Treatments: Dietary Supplement: FertyBiotic Balance

Study type: Interventional

Funder types: Industry

Identifiers

NCT05176535

2021-FBB-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 35 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

FertyBiotic Balance

Experimental group

Description:

Participants received FertyBiotic Balance one capsule a day

Treatment:

Dietary Supplement: FertyBiotic Balance