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Could a probiotic and laser ease menopause symptoms?

NCT ID NCT06978907

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a daily probiotic (Lactobacillus crispatus M247) combined with vaginal laser therapy can improve vaginal health and reduce symptoms like dryness, itching, and pain in menopausal women with atrophic vulvovaginitis. 75 women were split into two groups: one received laser alone, the other laser plus the probiotic. Researchers measured symptom changes and vaginal bacteria over three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lactobacillus crispatus M247 (Crispact®) probiotic
What this could lead to
If it works, this combination could offer a non-hormonal option to ease vaginal discomfort in menopausal women.
What could go wrong
This is a small, early study with only 75 participants. The probiotic may not significantly improve symptoms beyond laser alone, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

75 people

The number who actually took part.

Started

Jul 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Menopausal women with no menstrual cycle for \>12 months. * Diagnosed with atrophic vulvovaginitis (VVA) and experiencing related symptoms (vaginal dryness, introital and profound dyspareunia, itching, burning, bleeding during intercourse). * Symptoms related to genitourinary syndrome of menopause (GSM), including urinary urgency, increased frequency, nocturia, recurrent cystitis, or post-coital cystitis. * Prior negative PAP test performed within one year of enrollment. * Women who are unresponsive to or dissatisfied with prior topical estrogen therapy or who have contraindications to local and/or systemic estrogen prescription. Exclusion Criteria: * Pregnancy or breastfeeding. * Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva. * Active genital and/or urinary tract infections. * Dermatological contraindications to laser therapy. * Ongoing systemic or local hormone therapy. * Neurological or psychiatric disorders. * Chronic systemic diseases of autoimmune or dysmetabolic nature.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital State of Republic of San Marino

    San Mariano, 47893, Italy

  • Villa Margherita Clinic

    Roma, 00161, Italy

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