Probiotics in Women With Primary Dysmenorrhoea

Phase 2CompletedNCT04119011

National University of Malaysia72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Primary Dysmenorrhea

Interventions

ProbioticBIOLOGICAL

(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

PlaceboOTHER

lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National University of Malaysia

Cheras, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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