DysmenorrheaNCT07530081
The Impact of Oral Probiotics on Improving the Quality of Life in Patients With Dysmenorrhea.
A study testing High dose Probiotic and Low dose probiotic in people with Dysmenorrhea, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- High dose Probiotic and Low dose probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Dysmenorrhea
- Being tested
- High dose Probiotic, Low dose probiotic, Placebo
- Keywords
- Dysmenorrhea, Menstrual discomfort, Probiotics, Gut microbiota
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose ProbioticDietary supplement
Taking 1 capusle of high dose probiotic( L. rhamnosus F-1) twice daily.
Low dose probioticDietary supplement
Taking 1 capusle of low dose probiotic( L. rhamnosus F-1) twice daily
PlaceboDietary supplement
Subjects take one capusle containing maltodextrin twice daily.
| Study group | Role | What they receive |
|---|---|---|
| High dose Probiotic | Experimental | Not described Receives: Dietary Supplement: High dose Probiotic |
| Low dose Probiotic | Experimental | Not described Receives: Dietary Supplement: Low dose probiotic |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and the fourth menstrual cycle post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start4 Mar 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530081
- Sponsor's protocol ID
- CMUH112-REC3-145
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oral Probiotics on Improving the Quality of Life in Patients With Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT07530081
- Acronym / sponsor ID
- CMUH112-REC3-145
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea, Menstrual discomfort, Probiotics, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Glac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose Probiotic | Experimental | Dietary Supplement: High dose Probiotic |
| Low dose Probiotic | Experimental | Dietary Supplement: Low dose probiotic |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose ProbioticTaking 1 capusle of high dose probiotic( L. rhamnosus F-1) twice daily. | Dietary supplement | High dose Probiotic |
| Low dose probioticTaking 1 capusle of low dose probiotic( L. rhamnosus F-1) twice daily | Dietary supplement | Low dose Probiotic |
| PlaceboSubjects take one capusle containing maltodextrin twice daily. | Dietary supplement | Placebo |
Primary outcome
Changes in Numerical Rating Scale(NRS) scores
Time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
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.
Changes in the premenstrual symptoms screening tool(PSST) scores
Time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
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.
Changes in Menstrual Distress Questionnaire(MDQ) scores
Time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
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.
Changes in Short-Form McGill Pain Questionnaire(SF-MPQ) scores
Time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
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.
6 secondary outcomes
Changes in Pittsburgh Sleep Quality Index (PSQI) scores.
Time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention
Analysis of gut microbiota composition
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Analysis of vaginal microbiota composition
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Analysis of vaginal pH value change
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Changes in blood biochemical parameters
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Changes in urinary inflammatory markers.
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Related trials for Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose Probiotic and Low dose probiotic in people with Dysmenorrhea, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Numerical Rating Scale(NRS) scores (time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.