Probiotics in Women With Primary Dysmenorrhoea

Phase 1

Completed

• Conditions: Primary Dysmenorrhea
• Interventions: Biological: Probiotic; Other: Placebo

• Registration Number: NCT04119011
• Lead Sponsor: National University of Malaysia

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

Study Timeline

• Study First Submitted: 2019-09-30
• Study Start: 2019-10-01
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months
Placebo	Placebo	Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months

Primary Outcome Measures

Name	Time	Method
severity score before treatment (verbal rating score)	baseline	mean Verbal Rating Score on scale 0 to 3, on day 2 of menses at baseline
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
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
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
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 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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National University of Malaysia; 🇲🇾 Cheras, Kuala Lumpur, Malaysia