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| Name | Class |
|---|---|
| B-Crobes Marketing(M) Sdn Bhd | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months |
|
| Placebo | Placebo Comparator | Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Biological | (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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nur Azurah Abd Ghani | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Malaysia | Cheras | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38444064 | Derived | Zakaria IA, Mohammed Zain NA, Teik CK, Abu MA, Zainuddin AA, Abdul Aziz NH, Safian N, Mohd Mokhtar N, Raja Ali RA, Beng Kwang N, Mohamed Ismail NA, Hamizan MR, Ab Razak WS, Nur Azurah AG. The role of probiotics in improving menstrual health in women with primary dysmenorrhoea: A randomized, double-blind, placebo-controlled trial (the PERIOD study). Womens Health (Lond). 2024 Jan-Dec;20:17455057241234524. doi: 10.1177/17455057241234524. |
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clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)
20 months
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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randomized placebo-controlled trial
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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
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| Placebo | Other | lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor |
|
| 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 |
| 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 |
| D019602 |
| Food and Beverages |