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

NCT07530081 | Active Not Recruiting

• 1 other identifier: CMUH112-REC3-145
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysmenorrhea

Keywords

Dysmenorrhea; Menstrual discomfort; Probiotics; Gut microbiota

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

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

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

• Analysis of gut microbiota composition

  Baseline and the fourth menstrual cycle post-intervention.

• Analysis of vaginal microbiota composition

  Baseline and the fourth menstrual cycle post-intervention.

• Analysis of vaginal pH value change

  Baseline and the fourth menstrual cycle post-intervention.

• Changes in blood biochemical parameters

  Baseline and the fourth menstrual cycle post-intervention.

Study Arms (3)

High dose Probiotic

EXPERIMENTAL

Dietary Supplement: High dose Probiotic

Low dose Probiotic

EXPERIMENTAL

Dietary Supplement: Low dose probiotic

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

High dose Probiotic DIETARY_SUPPLEMENT

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

High dose Probiotic

Low dose probiotic DIETARY_SUPPLEMENT

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

Low dose Probiotic

Placebo DIETARY_SUPPLEMENT

Subjects take one capusle containing maltodextrin twice daily.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Glac Biotech Co., Ltd: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Development Director

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: March 4, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

TW (1)