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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dysmenorrhea
• Intervention / Treatment: Dietary supplement: High dose Probiotic; Dietary supplement: Low dose probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female aged between 20 and 65 years.
• Regular menstrual cycles.
• During the last three menstrual periods, self-reported dysmenorrhea with a pain score ≥ 3 on the Numeric Rating Scale (NRS).
• Able to use effective contraception during the study period.
• Willing to participate in the study and has signed the informed consent form.

Exclusion Criteria:

• Planning to become pregnant, currently pregnant, or in the postpartum stage with menstruation not yet resumed.
• Postmenopausal women.
• Irregular menstrual cycles (cycle length < 21 days or > 40 days).
• Currently taking any psychiatric medications, oral contraceptives, menstrual regulation drugs, weight-loss drugs, or antibiotics.
• Consumption of probiotic-related products within the past 1 month (including drops, tablets, capsules, powder, or yogurt and fermented milk products).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Subjects take one capusle containing maltodextrin twice daily.
Experimental: High dose Probiotic	Dietary supplement: High dose Probiotic; Taking 1 capusle of high dose probiotic( L. rhamnosus F-1) twice daily.
Experimental: Low dose Probiotic	Dietary supplement: Low dose probiotic; Taking 1 capusle of low dose probiotic( L. rhamnosus F-1) twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Numerical Rating Scale(NRS) scores	Changes in Numerical Rating Scale(NRS) scores were assessed before and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention. The minimum value is "0" and maximum value is "10", higher scores mean a worse outcome.	Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
Changes in the premenstrual symptoms screening tool(PSST) scores	Changes in the premenstrual symptoms screening tool(PSST) scores were assessed before and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention. The minimum value is "19" and maximum value is "76", higher scores mean a worse outcome.	Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
Changes in Menstrual Distress Questionnaire(MDQ) scores	Changes in Menstrual Distress Questionnaire(MDQ) scores were assessed before and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention. The minimum value is "16" and maximum value is "64", higher scores mean a worse outcome.	Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
Changes in Short-Form McGill Pain Questionnaire(SF-MPQ) scores	Changes in Short-Form McGill Pain Questionnaire(SF-MPQ) scores were assessed before and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention. The minimum value is "15" and maximum value is "60", higher scores mean a worse outcome.	Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pittsburgh Sleep Quality Index (PSQI) scores.	Changes in Pittsburgh Sleep Quality Index (PSQI) scores were assessed before and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention. The minimum value is "0" and maximum value is "21", higher scores mean a worse outcome.	Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
Analysis of gut microbiota composition	Changes in gut microbiota ratios were assessed by NGS before and the fourth menstrual cycle post-intervention.	Baseline and the fourth menstrual cycle post-intervention.
Analysis of vaginal microbiota composition	Changes in vaginal microbiota ratios were assessed by NGS before and the fourth menstrual cycle post-intervention.	Baseline and the fourth menstrual cycle post-intervention.
Analysis of vaginal pH value change	Changes in vaginal pH value were assessed before and the fourth menstrual cycle post-intervention.	Baseline and the fourth menstrual cycle post-intervention.
Changes in blood biochemical parameters	Changes in progesterone and PGE2 before and the fourth menstrual cycle post-intervention.	Baseline and the fourth menstrual cycle post-intervention.
Changes in urinary inflammatory markers.	Changes in leukocyte esterase before and the fourth menstrual cycle post-intervention.	Baseline and the fourth menstrual cycle post-intervention.

Collaborators and Investigators

• Sponsor: Glac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; Dysmenorrhea; Gut microbiota; Menstrual discomfort
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysmenorrhea; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: CMUH112-REC3-145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No