The effect of the oral probiotic on some parameters of the vaginal health

The effect of the Lactofem oral probiotic Capsule on the Lactobacilli colonization and some parameters of the vaginal health in women 18-55 year’s old admitted to the Health Centers of Shiraz University Medical Science in 2015.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015062322892N1

Enrollment

Registered

2015-09-04

Start date

2015-05-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal health. Foreign body in vulva and vagina

Interventions

Intervention 1: The oral probiotic capsule which contains a large amount of probiotic such as L. Acidophilus, L. plantarum, L. fermentum and L. gasseri are given one 500 milligram capsule during six

Treatment - Drugs

Placebo

The oral probiotic capsule which contains a large amount of probiotic such as L. Acidophilus, L. plantarum, L. fermentum and L. gasseri are given one 500 milligram capsule during sixty days.

Placebo capsule which are orally given one capsule per day during 60 days.

Eligibility

Sex/Gender

Female

Age

18 Years to 54 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The age 18-55 years; married; nonpregnant women; willing to participate in study; having natural menstrual cycles; nonsmokers; Nugent score = 4-6; pH >4.5; clinically, the samples not suffered any vaginitis; not suffered from such disease as liver, heart, kidney, diabetes, nervous system ailments, immunodeficiency, sexually transmitted illnesses; non-abnormal vaginal bleedings Exit criteria: pregnancy occurrence during the study; the use of vast spectrum antibiotics, hormonal drugs, alcohol, anticoagulation drugs and the recent month immunosuppressive; infection existence; ulcers, injury and abnormal secretions in the vulve, vagina and cervix examinations; sensitivity symptoms against oral probiotic; suspension with going on the study participation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Vaginal pH. Timepoint: respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Method of measurement: Test strip Merck Germany.;Nugent score. Timepoint: respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Method of measurement: Take smear from vagina with a cotton swab and make a direct smear on a microscope slide . In the laboratory the smears were stained and observed under the microscope to estimate nugent score.;Lactobacillus colonization of vagina. Timepoint: respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Method of measurement: Coun Lactobacillus.	—

Measure

Time frame

Vaginal pH. Timepoint: respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Method of measurement: Test strip Merck Germany.;Nugent score. Timepoint: respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Method of measurement: Take smear from vagina with a cotton swab and make a direct smear on a microscope slide . In the laboratory the smears were stained and observed under the microscope to estimate nugent score.;Lactobacillus colonization of vagina. Timepoint: respectively after 10, 30, 60 and 70 days of consuming probiotic or placebo in two study groups. Method of measurement: Coun Lactobacillus.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Azima

Fatemeh (PBUH) College of Nursing and Midwifery

azimas@sums.ac.ir+98 71 3647 4258

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026