Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, Menstrual discomfort, Probiotics, Gut microbiota
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.
Interventions
DIETARY_SUPPLEMENTHigh dose Probiotic
Taking 1 capusle of high dose probiotic( L. rhamnosus F-1) twice daily.
DIETARY_SUPPLEMENTLow dose probiotic
Taking 1 capusle of low dose probiotic( L. rhamnosus F-1) twice daily
DIETARY_SUPPLEMENTPlacebo
Subjects take one capusle containing maltodextrin twice daily.
Sponsors
Glac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Numerical Rating Scale(NRS) scores | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pittsburgh Sleep Quality Index (PSQI) scores. | 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. |
| Analysis of gut microbiota composition | 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. |
| Analysis of vaginal microbiota composition | 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. |
| Analysis of vaginal pH value change | Baseline and the fourth menstrual cycle post-intervention. | Changes in vaginal pH value were assessed before and the fourth menstrual cycle post-intervention. |
| Changes in blood biochemical parameters | Baseline and the fourth menstrual cycle post-intervention. | Changes in progesterone and PGE2 before and the fourth menstrual cycle post-intervention. |
| Changes in urinary inflammatory markers. | Baseline and the fourth menstrual cycle post-intervention. | Changes in leukocyte esterase before and the fourth menstrual cycle post-intervention. |
Countries
Taiwan
Outcome results
None listed