Probiotics in Women With Primary Dysmenorrhoea

A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial

This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea

Study Overview

• Status: Completed
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Biological: Probiotic; Other: Placebo

Detailed Description

This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • National University of Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic; Probiotic in powder form containing lactobacillus and bifidobacterium strains, sugar, milk powder and flavoring, taken 2 sachets daily for 3 months	Biological: Probiotic; (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
PLACEBO_COMPARATOR: Placebo; Placebo in powder form containing sugar, milk powder, flavoring, taken 2 sachets daily for 3 months	Other: Placebo; lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Collaborators: B-Crobes Marketing(M) Sdn Bhd
• Investigators: Principal Investigator: Nur Azurah Abd Ghani, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: probiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: FF-2018-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: clinical data sheet containing demographics, data collection (pain score, quality of life questionnaire, pain diary)
• IPD Sharing Time Frame: 20 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No