The Impact of Oral Probiotics on Improving the Quality of Life in Patients With Dysmenorrhea.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes in Numerical Rating Scale(NRS) scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
High dose Probiotic
干预措施: High dose Probiotic (Dietary Supplement)
Low dose Probiotic
干预措施: Low dose probiotic (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in Numerical Rating Scale(NRS) scores
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Changes in urinary inflammatory markers.(Baseline and the fourth menstrual cycle post-intervention.)
研究者
Hsieh-Hsun Ho
Research and Development Director
Glac Biotech Co., Ltd