A Phase 1/2 interventional study of Probiotic and Placebo in Primary Dysmenorrhea, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by National University of Malaysia · Phase 1/2, Interventional, and Treatment
This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea
This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months
Biological: Probiotic
Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months
Other: Placebo
(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
lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
pain score before treatment (visual analog scale VAS)
mean Visual Analog Score on scale 0 to 10, on day 2 of menses at baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months during treatment with probiotic or placebo
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
Time frame: 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
Time frame: At 3 months after commencement of treatment
intestinal microbiota before and after treatment with probiotics
Relative abundance of microbiome DNA in percentage
Time frame: on date of randomization and at 3 month after completed treatment with probiotic or placebo
Plan to share: Yes — clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University of Malaysia