NCT07530081

The Impact of Oral Probiotics on Improving the Quality of Life in Patients With Dysmenorrhea.

Active, enrolled NA Last updated 15 April 2026

What this trial tests

NA trial testing High dose Probiotic in Dysmenorrhea in 150 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 March 2024

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	Glac Biotech Co., Ltd
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	4 March 2024
Primary completion	30 June 2026
Estimated completion	30 June 2026
Sites	1 location across Taiwan

Drugs / interventions tested

• High dose Probiotic
• Low dose probiotic
• Placebo

Conditions studied

• Dysmenorrhea — all drugs for Dysmenorrhea →

Sponsor

Glac Biotech Co., Ltd

Who can join

Adults 20 to 65, female only, with Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Menstrual pain is mainly divided into primary dysmenorrhea and secondary dysmenorrhea, the former is caused by menstrual uterine muscle movement; the latter is caused by certain diseases, such as Endometriosis, Uterine fibroids and Pelvic inflammatory disease. Menstrual pain has been a troubling issue for many women. The most common type of menstrual pain is at the lower abdomen. For some girls, menstrual pain is accompanied by nausea, diarrhea, fatigue, headache, flatulence, etc.

In addition to menstrual pain, Premenstrual syndrome (PMS) is also one of the problems that affect women's physical and mental health. PMS, as the name suggests, these symptoms appear before menstruation. During the periods, the symptoms will gradually disappear and before the next menstruation it will appear again.

About 80% women in Taiwan have experienced with menstrual pain or premenstrual discomfort. It affects the physical, psychological and social status of most women, and the degree of menstrual pain can also affect mood, sleep quality,school and work efficiency. Although there are many ways to relieve menstrual pain, hot compresses or oral painkillers, contraceptive pills, etc., but these medications are not without side effects.

Probiotics are defined as live microorganisms that, in sufficient quantities, benefit the health of the host. They are mainly bacteria that produce lactic acid, including Lactobacilli, Bifidobacteria, and Saccharomyces boulardii. Most studies have pointed out that probiotics can reduce the severity of gastrointestinal symptoms. Some studies have also pointed out that probiotics can improve physical and psychological functions, such as depression and sleep quality. In addition, animal experiments have shown that probiotics can regulate GABA in mice A and GABA B receptor expression to alter mood.

This study aims to explore whether probiotic supplementation can improve menstrual pain and menstrual discomfort symptoms. If these common menstrual problems can be improved by probiotics, it will be a great significance to improve the quality of life of women. The trial lasts for 8 menstrual cycles, including 2 menstrual cycles in the screening period, 4 menstrual cycles in the test period and 2 menstrual cycles in the follow-up period. This trial will performed in China Medical University Hospital.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.