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NCT Number: NCT07530081

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

High dose Probiotic

Dietary Supplement

Taking 1 capusle of high dose probiotic( L. rhamnosus F-1) twice daily.

Low dose probiotic

Dietary Supplement

Taking 1 capusle of low dose probiotic( L. rhamnosus F-1) twice daily

Placebo

Dietary Supplement

Subjects take one capusle containing maltodextrin twice daily.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Changes in Pittsburgh Sleep Quality Index (PSQI) scores.

    Time frame: Baseline and the 1st, 2nd, 3rd, 4th, 5th, and 6th menstrual cycles post-intervention

    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.

  2. Analysis of gut microbiota composition

    Time frame: Baseline and the fourth menstrual cycle post-intervention.

    Changes in gut microbiota ratios were assessed by NGS before and the fourth menstrual cycle post-intervention.

  3. Analysis of vaginal microbiota composition

    Time frame: Baseline and the fourth menstrual cycle post-intervention.

    Changes in vaginal microbiota ratios were assessed by NGS before and the fourth menstrual cycle post-intervention.

  4. Analysis of vaginal pH value change

    Time frame: Baseline and the fourth menstrual cycle post-intervention.

    Changes in vaginal pH value were assessed before and the fourth menstrual cycle post-intervention.

  5. Changes in blood biochemical parameters

    Time frame: Baseline and the fourth menstrual cycle post-intervention.

    Changes in progesterone and PGE2 before and the fourth menstrual cycle post-intervention.

  6. Changes in urinary inflammatory markers.

    Time frame: Baseline and the fourth menstrual cycle post-intervention.

    Changes in leukocyte esterase before and the fourth menstrual cycle post-intervention.

Sponsors and collaborators

Lead sponsor

Glac Biotech Co., Ltd

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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