Primary Dysmenorrhea
Conditions
Keywords
probiotics
Brief summary
This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea
Detailed description
This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea
Interventions
BIOLOGICALProbiotic
(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
OTHERPlacebo
lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
Sponsors
B-Crobes Marketing(M) Sdn Bhd
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
placebo and probiotic are labelled A or B, this is prepared by the manufacturer and blinded from the participant and investigator, the unblinding takes place only after completion of the data collection
Intervention model description
randomized placebo-controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group | 3 months during treatment with probiotic or placebo | mean number of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use per cycle |
| severity score after treatment (verbal rating score) | after 3 months of treatment | mean Verbal Rating Score on scale 0 to 3, on day 2 of menses after 3 months of treatment with placebo/probiotic |
| Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire) | baseline | 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 |
| Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire) | at 3 months after completed treatment with probiotic or placebo | 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 |
| pain score before treatment (visual analog scale VAS) | baseline | mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline |
| pain score after treatment (visual analog scale VAS) | after 3 months of treatment | mean Visual Analog Score on scale 0 to 10, on day 2 of menses after 3 months of treatment with probiotic/placebo |
| severity score before treatment (verbal rating score) | baseline | mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of inflammatory markers post-treatment | At 3 months after commencement of 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 |
| intestinal microbiota before and after treatment with probiotics | on date of randomization and at 3 month after completed treatment with probiotic or placebo | Relative abundance of microbiome DNA in percentage |
| Concentration of inflammatory markers pre-treatment | baseline | 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 |
Countries
Malaysia
Outcome results
None listed