Probiotics in Women With Primary Dysmenorrhoea

Study Overview
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Brief Summary
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This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea

Detailed Description
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This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea

Official Title
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A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Biological: Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: regular menstrual cycles between 21 to 45 days primary dysmenorrhoea only willing to consume sachets twice daily for 3 months Exclusion Criteria: current Intrauterine Copper Device (IUCD) user recent hormonal (estrogen or progesterone) therapy in last 3 months on treatment for allergy such as antihistamine diarrhoea with dairy product often take drugs which may affect the test results (such as medicines treating constipation or digestive medicine such as laxatives or enema) any malignant tumor regardless of type or site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized placebo-controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months | Biological: Probiotic<br>* (Lactobacillus acidophilus, lactobacillus casei, lactobacillus lactis) and Bifidobacterium (Bifidobacterium bifidum, bifidobacterium longum, bifidobacterium infantis) lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor<br>|
| Placebo Comparator: Placebo<br>Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months | Other: Placebo<br>* lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score before treatment (visual analog scale VAS) | mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline | baseline | 
| pain score after treatment (visual analog scale VAS) | mean Visual Analog Score on scale 0 to 10, on day 2 of menses after 3 months of treatment with probiotic/placebo | after 3 months of treatment | 
| severity score before treatment (verbal rating score) | mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline | baseline | 
| severity score after treatment (verbal rating score) | mean Verbal Rating Score on scale 0 to 3, on day 2 of menses after 3 months of treatment with placebo/probiotic | after 3 months of treatment | 
| Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire) | mean quality of life score using validated health survey questionnaire Short Form 12 version 2 (SF12v2) (permission obtained from primary author) Answers from each question will be calculated using formula into percentage of average physical health score and average mental health score, on scale 0 to 100 in which higher percentage represents higher quality of life, and score less than 50 represents poor quality of life | baseline | 
| Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire) | mean quality of life score using validated health survey questionnaire Short Form 12 version 2 (SF12v2) (permission obtained from primary author) Answers from each question will be calculated using formula into percentage of average physical health score and average mental health score, on scale 0 to 100 in which higher percentage represents higher quality of life, and score less than 50 represents poor quality of life | at 3 months after completed treatment with probiotic or placebo | 
| Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group | mean number of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use per cycle | 3 months during treatment with probiotic or placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of inflammatory markers pre-treatment | mean concentration of serum pro-inflammatory markers on day 2 of menses (Interleukin-1,2,4,5,6,7,8,10,12p70,13,17, Tumour necrosis factor-alpha, Granulocyte Colony Stimulating Factor, and Regulated on activation normal T-cell expressed and secreted) all in pg/mL, reported individually in table form | baseline | 
| Concentration of inflammatory markers post-treatment | mean concentration of serum pro-inflammatory markers on day 2 of menses (Interleukin-1,2,4,5,6,7,8,10,12p70,13,17, Tumour necrosis factor-alpha, Granulocyte Colony Stimulating Factor, and Regulated on activation normal T-cell expressed and secreted) all in pg/mL, reported individually in table form | At 3 months after commencement of treatment | 
| intestinal microbiota before and after treatment with probiotics | Relative abundance of microbiome DNA in percentage | on date of randomization and at 3 month after completed treatment with probiotic or placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics