Clinical trial NCT05326217: The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome
Official title: The Effects of Exercise and Probiotics on the Efficacy and Possible Mechanisms of Dysmenorrhea From the Perspective of Microbiome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Inflammation
Microbial Substitution
Keywords: Lactobacillus
Sport nutrition
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.

Detailed description: In current study, there were two stages designed for current study. The definition of dysmenorrhea population depended on the Visual Analogue Scale (VAS) of McGill Pain Questionnaire (more than 5) and the VAS score less than 2 was considered as non-dysmenorrhea population.

In the first stage, the 20 subjects were recruit for non-dysmenorrhea group (Control group) and other 60 subjects were randomly allocated into three group with original lifestyle, aerobic, and resistant exercise intervention (Dys-Control, Dys-Aerobic, and Dys-resistant groups). The questionnaires (Premenstrual syndrome, the Menstrual Distress, and McGill Pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated exercise training.

In the second stage, one hundred subjects (20 non-dysmenorrhea and 80 dysmenorrhea populations) will be recruited and the dysmenorrhea will be randomly allocated into Dys-Control, Dys-probiotics, Dys-exercise and Dys-probiotics and exercise groups. The questionnaires (Premenstrual syndrome, the Menstrual Distress, and McGill Pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated interventions (probiotics and exercise).

Eligibility criteria: Inclusion Criteria:

* Primary dysmenorrhea
* Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; \>5 for dysmenorrhea)

Exclusion Criteria:

* Pregnancy, menstrual disorders, obesity (BMI\>30), smoking, and alcohol or drug addiction
* Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness

Primary outcomes:
measure: The effects of different types of exercise on premenstrual syndrome questionnaire with dysmenorrhea
timeFrame: 10 weeks
measure: The effects of different types of exercise on menstrual distress questionnaire with dysmenorrhea
timeFrame: 10 weeks
measure: The effects of different types of exercise on McGill pain questionnaire with dysmenorrhea
timeFrame: 10 weeks
measure: The effects of different types of exercise on cardiovascular capacity
timeFrame: 10 weeks
measure: The effects of different types of exercise on muscular strength of upper limbs
timeFrame: 10 weeks
measure: The effects of different types of exercise on power
timeFrame: 10 weeks
measure: The effects of different types of exercise on core strength
timeFrame: 10 weeks
measure: The effects of different types of exercise on body composition
timeFrame: 10 weeks
measure: The microbiome succession of the dysmenorrhea with different types of exercise intervention
timeFrame: 10 weeks
measure: The effects of different types of exercise on cytokines in dysmenorrhea
timeFrame: 10 weeks
measure: The effects of different types of exercise on biochemistries in dysmenorrhea
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Wen Ching Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: