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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Placebo: Subjects take one capusle containing maltodextrin twice daily.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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