China Medical University Hospital
Taichung, 404, Taiwan
NCT Number: NCT07530081
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.
This study is active but is not currently recruiting participants.
Notify Me20 year–65 year
Female
Interventional
Not applicable
Taichung, 404, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Taking 1 capusle of high dose probiotic( L. rhamnosus F-1) twice daily.
Taking 1 capusle of low dose probiotic( L. rhamnosus F-1) twice daily
Subjects take one capusle containing maltodextrin twice daily.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Changes in progesterone and PGE2 before and the fourth menstrual cycle post-intervention.
Time frame: Baseline and the fourth menstrual cycle post-intervention.
Changes in leukocyte esterase before and the fourth menstrual cycle post-intervention.
Glac Biotech Co., Ltd
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT07544511
Dysmenorrhea, Menstruation Disturbances
Malatya, Turkey (Türkiye)
View Trial DetailsNCT07598929
Adherence Interventions, Artificial Intelligence
Merkez, Sivas, Turkey (Türkiye)
View Trial DetailsNCT01738204
Dysmenorrhea, Endometriosis
Boston, Massachusetts, United States
View Trial DetailsNCT07081789
Dysmenorrhea, Menstruation Disturbances
Burdur, Bucak, Turkey (Türkiye)
View Trial Details